Over-the-counter drug · ANDA
Guaifenesin and Pseudoephedrine HCl NDC 51660-077
Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Extended release · Oral · Ohm Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51660-077-12 | 5166000771251660007712 | 1 BLISTER PACK in 1 CARTON (51660-077-12) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 1, 2021 |
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 — 1200 mg/1Pseudoephedrine hydrochloride — 120 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Ohm Laboratories, Inc.NDC labeler code 51660
- 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 51660-077_2522057d-9a67-f0f3-e063-6394a90af3f5SPL ID 2522057d-9a67-f0f3-e063-6394a90af3f5SPL set ID 2521ecd3-28f3-a13c-e063-6394a90a7245RxCUI 1244675, 1305603UNII 495W7451VQ, 6V9V2RYJ8NUPC 0351660077124, 0351660074185
- 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
N451660007712followed by a unit qualifier and the quantityPackage 51660-0077-12. 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 51660-077
- What is NDC 51660-077?
- 51660-077 is the product NDC for Guaifenesin and Pseudoephedrine HCl, Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, extended release, listed with the FDA by Ohm Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Guaifenesin and Pseudoephedrine HCl.
- What is the active ingredient?
- Guaifenesin, Pseudoephedrine hydrochloride.
- Who is the labeler?
- Ohm Laboratories, Inc., NDC labeler code 51660. 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 HCl?
- 14 other product NDCs are listed under this name. See all Guaifenesin and Pseudoephedrine HCl 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 HCl 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 HCl | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1263 | 70677-1263-01 |
| Guaifenesin and Pseudoephedrine HCl | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | Amerisource Bergen | 46122-801 | 46122-0801-08 |
| Guaifenesin and Pseudoephedrine HCl | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | Granules India Ltd | 62207-827 | 62207-0827-72 |
| Guaifenesin and Pseudoephedrine HCl | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Granules India Ltd | 62207-828 | 62207-0828-71 |
| Guaifenesin and Pseudoephedrine HCl | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | WALGREEN CO. | 0363-9946 | 00363-9946-4000363-9946-45 |
| Guaifenesin and Pseudoephedrine HCl | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | Rite Aid Corporation | 11822-0046 | 11822-0046-0111822-0046-02 |
| Guaifenesin and Pseudoephedrine HCl | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | Meijer | 79481-1002 | 79481-1002-01 |
| Guaifenesin and Pseudoephedrine HCl | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 30142-137 | 30142-0137-1230142-0137-17 |
| Guaifenesin and Pseudoephedrine HCl | Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Extended releaseOral | Ohm Laboratories, Inc. | 51660-074 | 51660-0074-18 |
| Guaifenesin and Pseudoephedrine HCl | Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | WALGREEN CO. | 0363-0134 | 00363-0134-78 |
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 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 | PUBLIX SUPER MARKETS, INC | 41415-994 |
| 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 |