Over-the-counter drug · ANDA
Guaifenesin and Pseudoephedrine Hydrochloride NDC 41415-994
Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 · Tablet, Extended release · Oral · PUBLIX SUPER MARKETS, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41415-994-18 | 4141509941841415099418 | 1 BLISTER PACK in 1 CARTON (41415-994-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 7, 2022 | |
| 41415-994-36 | 4141509943641415099436 | 2 BLISTER PACK in 1 CARTON (41415-994-36) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 7, 2022 |
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 Hydrochloride
- Generic name (nonproprietary)
- guaifenesin and pseudoephedrine hydrochloride
- Active ingredients
- Guaifenesin — 600 mg/1Pseudoephedrine hydrochloride — 60 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- PUBLIX SUPER MARKETS, INCNDC labeler code 41415
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212542
- 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 41415-994_a36d0524-b1d7-4daf-a62e-54f63168b0cdSPL ID a36d0524-b1d7-4daf-a62e-54f63168b0cdSPL set ID c857bcd9-6696-40d5-93c0-65097598cd4bRxCUI 1305603UNII 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
N441415099418followed by a unit qualifier and the quantityPackage 41415-0994-18. 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.
About NDC 41415-994
- What is NDC 41415-994?
- 41415-994 is the product NDC for Guaifenesin and Pseudoephedrine Hydrochloride, Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 tablet, extended release, listed with the FDA by PUBLIX SUPER MARKETS, INC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Guaifenesin and Pseudoephedrine Hydrochloride.
- What is the active ingredient?
- Guaifenesin, Pseudoephedrine hydrochloride.
- Who is the labeler?
- PUBLIX SUPER MARKETS, INC, NDC labeler code 41415. 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 Pseudoephedrine Hydrochloride?
- 2 other product NDCs are listed under this name. See all Guaifenesin and Pseudoephedrine Hydrochloride 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 Pseudoephedrine Hydrochloride 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 Pseudoephedrine Hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | STRATEGIC SOURCING SERVICES LLC | 62011-0475 | 62011-0475-01 |
| Guaifenesin and Pseudoephedrine Hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | WALGREEN COMPANY | 0363-0077 | 00363-0077-1800363-0077-36 |
Other NDCs under ANDA 212542
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 | Ohm Laboratories, Inc. | 51660-074 |
| Guaifenesin and Pseudoephedrine HCl | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Ohm Laboratories, Inc. | 51660-077 |
| Guaifenesin and Pseudoephedrine HCl | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1263 |
| Guaifenesin and Pseudoephedrine Hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | STRATEGIC SOURCING SERVICES LLC | 62011-0475 |
| Guaifenesin Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | Walgreen Company | 0363-9930 |
| Guaifenesin Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | RUGBY LABORATORIES, INC. | 0536-1333 |
| Guaifenesin Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy, Inc. | 51316-993 |
| MAXIMUM STRENGTH Mucus Dguaifenesin and pseudoephedrine hydrochloride | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy | 51316-970 |