Over-the-counter drug · ANDA
Maximum Strength Guaifenesin DM NDC 0536-1213
guaifenesin, dextromethorphan hbr · Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 · Tablet, Extended release · Oral · Rugby Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-1213-88 | 00536121388 | 14 BLISTER PACK in 1 CARTON (0536-1213-88) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Nov 5, 2018 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Maximum Strength Guaifenesin DM
- Generic name (nonproprietary)
- guaifenesin, dextromethorphan hbr
- Active ingredients
- Dextromethorphan hydrobromide — 60 mg/1Guaifenesin — 1200 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Rugby Laboratories
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209692
- Marketing start
- Marketing end
- 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 0536-1213_74767680-e4e7-4ba6-8d45-a01cd0471317SPL ID 74767680-e4e7-4ba6-8d45-a01cd0471317SPL set ID 2c9515f8-3120-4dbb-a7fc-d89fc5727148RxCUI 1099074UNII 9D2RTI9KYH, 495W7451VQUPC 0305361213886
- 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
N400536121388followed by a unit qualifier and the quantityPackage 00536-1213-88. 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.
Other NDCs under ANDA 209692
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 |
|---|---|---|---|---|
| Mucus Relief DM Extended Release Capletsguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | TabletOral | Cardinal Health (Leader) 70000 | 70000-0464 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1049 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1050 |
| Mucus Relief DM Extended Release Caplets Maximum Strengthguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | TabletOral | Walgreens | 0363-0437 |
| Mucus Relief DM Extended Release Capletsguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | TabletOral | A-S Medication Solutions | 50090-6020 |
| Mucus Relief DM Extended Release Capletsguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Rugby Laboratories | 0536-1161 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | TabletOral | Care One (Retail Business Services, LLC.) | 72476-734 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | Care One (Retail Business Services, LLC.) | 72476-733 |
| Mucus Relief DM Maximum Strengthguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | TabletOral | Chain Drug Consortium, LLC | 68016-674 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | WinCo Foods, LLC | 67091-344 |
| Mucus Relief DM Maximum Strengthguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | TabletOral | WinCo Foods, LLC | 67091-345 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | Rite Aid Corporation | 11822-0733 |
| Mucus Relief DM Extended Release Capletsguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | TabletOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-824 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | FSA Store Inc. (Caring Mills) | 81522-734 |
| Mucus Relief DM Maximum Strengthguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | TabletOral | Rite Aid Corporation | 11822-7340 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-038 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-039 |
| Mucus Relief DM Extended Release Capletsguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | Walgreens | 0363-0733 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-733 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | H E B | 37808-730 |
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