Over-the-counter drug · ANDA
Guaifenesin and Pseudoephedrine HCL NDC 55111-798
Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 · Tablet, Extended release · Oral · Dr. Reddys Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-798-09 | 55111079809 | 1 BLISTER PACK in 1 CARTON (55111-798-09) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 29, 2017 | |
| 55111-798-18 | 55111079818 | 2 BLISTER PACK in 1 CARTON (55111-798-18) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 29, 2017 | |
| 55111-798-35 | 55111079835 | 1 BLISTER PACK in 1 CARTON (55111-798-35) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jan 23, 2020 | |
| 55111-798-36 | 55111079836 | 4 BLISTER PACK in 1 CARTON (55111-798-36) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 29, 2017 | |
| 55111-798-41 | 55111079841 | 2 BLISTER PACK in 1 CARTON (55111-798-41) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 11, 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 Pseudoephedrine HCL
- Generic name (nonproprietary)
- guaifenesin and pseudoephedrine hcl
- Active ingredients
- Guaifenesin — 600 mg/1Pseudoephedrine hydrochloride — 60 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208369
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 55111-798_9e158de3-9d7a-e6f8-2e19-5ef46d33e8cdSPL ID 9e158de3-9d7a-e6f8-2e19-5ef46d33e8cdSPL set ID 845a2dcc-9069-3141-ae13-f2063f36d130RxCUI 1244675, 1305603UNII 6V9V2RYJ8N, 495W7451VQ
- Pharmacologic class
- Expectorant; alpha-Adrenergic Agonist
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
N455111079809followed by a unit qualifier and the quantityPackage 55111-0798-09. 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)
Use(s) ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive ■ temporarily relieves nasal congestion due to: ■ common cold ■ hay fever ■ upper respiratory allergies ■ temporarily restores freer breathing through the nose ■ promotes nasal and/or sinus drainage ■ temporarily relieves sinus congestion and pressure
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208369
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 Dguaifenesin and pseudoephedrine hcl | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | CVS Health Corp | 69842-211 |
| Guaifenesin and Pseudoephedrine HCL | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Dr. Reddys Laboratories Limited | 55111-799 |
| Guaifenesin and Pseudoephedrine HCl | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services, LLC | 70677-1011 |
| Guaifenesin and Pseudoephedrine HCl | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | Rite Aid Corporation | 11822-0046 |
| Mucus Relief Dguaifenesin and pseudoephedrine hcl | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Walgreens Company | 0363-7064 |
| Mucus Relief Dguaifenesin and pseudoephedrine hcl | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | Walgreens Company | 0363-1604 |
| Mucus Relief Dguaifenesin and pseudoephedrine hcl | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Rite Aid Corporation | 11822-7399 |
| Mucus Relief Dguaifenesin and pseudoephedrine hcl | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Wal-mart Stores, Inc. | 49035-261 |
| Mucus Dguaifenesin 600 mg and pseudoephedrine hcl 60 mg | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | CVS Health Corp | 69842-095 |