Over-the-counter drug · ANDA
Guaifenesin and Pseudoephedrine HCl NDC 0363-0134
Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Extended release · Oral · WALGREEN CO.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-0134-78 | 00363013478 | 2 BLISTER PACK in 1 CARTON (0363-0134-78) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 5, 2020 |
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)
- Guaifenesin and Pseudoephedrine HCl
- Generic name (nonproprietary)
- guaifenesin and pseudoephedrine hcl
- Active ingredients
- Guaifenesin — 1200 mg/1Pseudoephedrine hydrochloride — 120 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- WALGREEN CO.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213203
- 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 0363-0134_a8d412ac-63da-463b-a670-4d4c927b9782SPL ID a8d412ac-63da-463b-a670-4d4c927b9782SPL set ID 4c3b99f0-83af-4df0-a681-f2fc8778f8bbRxCUI 1244675UNII 495W7451VQ, 6V9V2RYJ8N
- 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
N400363013478followed by a unit qualifier and the quantityPackage 00363-0134-78. 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 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 213203
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 |
|---|---|---|---|---|
| Guaifenesin and Pseudoephedrine HCl | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | Meijer | 79481-1002 |
| Guaifenesin and Pseudoephedrine HCl | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 30142-137 |
| Guaifenesin and Pseudoephedrine HCl | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | Amerisource Bergen | 46122-801 |
| Guaifenesin and Pseudoephedrine HCl | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | WALGREEN CO. | 0363-9946 |
| Guaifenesin and Pseudoephedrine HCl | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-833 |
| Guaifenesin and Pseudoephedrine HCl | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-834 |