Over-the-counter drug · ANDA
Guaifenesin and Dextromethorphan HBr NDC 58602-849
Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 · Tablet, Extended release · Oral · Aurohealth LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)58602-849Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58602-0849Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-849-11 | 58602084911 | 8 BLISTER PACK in 1 CARTON (58602-849-11) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 13, 2020 | |
| 58602-849-15 | 58602084915 | 1 BOTTLE in 1 CARTON (58602-849-15) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Aug 13, 2020 | |
| 58602-849-57 | 58602084957 | 1 BOTTLE in 1 CARTON (58602-849-57) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Sep 8, 2020 | |
| 58602-849-64 | 58602084964 | 1 BLISTER PACK in 1 CARTON (58602-849-64) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Feb 24, 2021 | |
| 58602-849-65 | 58602084965 | 2 BLISTER PACK in 1 CARTON (58602-849-65) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from May 16, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Guaifenesin and Dextromethorphan HBr
- Generic name (nonproprietary)
- guaifenesin and dextromethorphan hbr
- Active ingredients
- Guaifenesin — 1200 mg/1Dextromethorphan hydrobromide — 60 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Aurohealth LLCNDC labeler code 58602
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206941
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 58602-849_72b8f474-79ca-4eaf-a036-8596d9ee9b2fSPL ID 72b8f474-79ca-4eaf-a036-8596d9ee9b2fSPL set ID 88bc399a-2b71-45a7-bdfb-226ff1df0536RxCUI 1099074UNII 495W7451VQ, 9D2RTI9KYHUPC 0358602849658
- Pharmacologic class
- Expectorant; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N458602084911followed by a unit qualifier and the quantityPackage 58602-0849-11. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep
Excerpt only. Read the full label for complete information.
About NDC 58602-849
- What is NDC 58602-849?
- 58602-849 is the product NDC for Guaifenesin and Dextromethorphan HBr, Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 tablet, extended release, listed with the FDA by Aurohealth LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Guaifenesin and Dextromethorphan HBr.
- What is the active ingredient?
- Guaifenesin, Dextromethorphan hydrobromide.
- Who is the labeler?
- Aurohealth LLC, NDC labeler code 58602. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Guaifenesin and Dextromethorphan HBr?
- 27 other product NDCs are listed under this name. See all Guaifenesin and Dextromethorphan HBr NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Guaifenesin and Dextromethorphan HBr products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Guaifenesin And Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | TOPCO ASSOCIATES LLC | 76162-032 | 76162-0032-56 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Target Corporation | 11673-267 | 11673-0267-0511673-0267-5711673-0267-60 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 30142-276 | 30142-0276-2030142-0276-40 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 30142-275 | 30142-0275-0530142-0275-14 |
| Guaifenesin and Dextromethorphan HBR | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Inc. | 43598-114 | 43598-0114-0143598-0114-2043598-0114-40 |
| Guaifenesin and Dextromethorphan HBR | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Inc. | 43598-115 | 43598-0115-2843598-0115-3243598-0115-37+3 more |
| Guaifenesin and Dextromethorphan HBR | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Inc. | 43598-231 | 43598-0231-01 |
| Guaifenesin and Dextromethorphan HBR | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Inc. | 43598-232 | 43598-0232-37 |
| Guaifenesin and Dextromethorphan HBR | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy | 51316-009 | 51316-0009-01 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | VESPYR BRANDS LLC | 71179-011 | 71179-0011-21 |
Other NDCs under ANDA 206941
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Amazon Basic Care Mucus DMguaifenesin and dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Amazon.com Services LLC | 72288-220 |
| Cough And Congestion Extended Releaseguaifenesin and dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy, Inc. | 51316-065 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Target Corporation | 11673-267 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 30142-275 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 30142-276 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-714 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-715 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-824 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-825 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-871 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | VESPYR BRANDS LLC | 71179-011 |
| Guaifenesin And Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | TOPCO ASSOCIATES LLC | 76162-032 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Sportpharm LLC | 85766-046 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Sportpharm LLC | 85766-150 |
| Maximum Strength Cough And Congestion Extended Releaseguaifenesin and dextromethorphan hbr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy, Inc. | 51316-060 |
| Maximum Strength Mucus DM Extended Releaseguaifenesin and dextromethorphan hbr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy, Inc. | 69842-059 |
| Maximum Strength Mucus Relief DMguaifenesin and dextromethorphan hbr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | WALGREEN CO. | 0363-0510 |
| Maximum Strength Mucus Relief DMguaifenesin and dextromethorphan hbr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Wal-Mart Stores, Inc. | 49035-956 |
| Mucus DMguaifenesin and dextromethorphan hbr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Amerisource Bergen | 46122-420 |
| Mucus DM Extended Releaseguaifenesin and dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy, Inc. | 69842-057 |
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