Over-the-counter drug · ANDA
Guaifenesin and Dextromethorphan Hydrobromide NDC 51316-600
Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 · Tablet, Extended release · Oral · CVS PHARMACY, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-600-70 | 5131606007051316060070 | 5 BLISTER PACK in 1 CARTON (51316-600-70) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 19, 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 Dextromethorphan Hydrobromide
- Generic name (nonproprietary)
- guaifenesin and dextromethorphan hydrobromide
- Active ingredients
- Guaifenesin — 1200 mg/1Dextromethorphan hydrobromide — 60 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- CVS PHARMACY, INCNDC labeler code 51316
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214781
- Marketing start
- Listing expires
- 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 51316-600_4fe39452-8d46-ba50-e063-6294a90ac53aSPL ID 4fe39452-8d46-ba50-e063-6294a90ac53aSPL set ID dd00dfc0-e523-4dec-8fc0-50363eadec57RxCUI 1099074UNII 495W7451VQ, 9D2RTI9KYH
- 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
N451316060070followed by a unit qualifier and the quantityPackage 51316-0600-70. 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.
About NDC 51316-600
- What is NDC 51316-600?
- 51316-600 is the product NDC for Guaifenesin and Dextromethorphan Hydrobromide, Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 tablet, extended release, listed with the FDA by CVS PHARMACY, INC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Guaifenesin and Dextromethorphan Hydrobromide.
- What is the active ingredient?
- Guaifenesin, Dextromethorphan hydrobromide.
- Who is the labeler?
- CVS PHARMACY, INC, NDC labeler code 51316. 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 Dextromethorphan Hydrobromide?
- 4 other product NDCs are listed under this name. See all Guaifenesin and Dextromethorphan Hydrobromide 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 Dextromethorphan Hydrobromide 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 Dextromethorphan Hydrobromide | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | SyrupOral | Method Pharmaceuticals | 58657-504 | 58657-0504-08 |
| Guaifenesin and Dextromethorphan Hydrobromide | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | SyrupOral | Bryant Ranch Prepack | 72162-2277 | 72162-2277-02 |
| Guaifenesin and Dextromethorphan Hydrobromide | Guaifenesin 400 mg/1; Dextromethorphan hydrobromide 20 mg/1 | TabletOral | InvaTech Pharma Solutions LLC | 57631-013 | 57631-0013-10 |
| Guaifenesin and Dextromethorphan Hydrobromide | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | SyrupOral | Method Pharmaceuticals | 58657-505 | 58657-0505-08 |
Other NDCs under ANDA 214781
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 Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Kroger Company | 30142-948 |
| Guaifenesin And Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Kroger Company | 30142-963 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | OHM LABORATORIES INC | 51660-110 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | OHM LABORATORIES INC | 51660-301 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | SUN PHARMACEUTICAL INDUSTRIES, INC. | 63304-106 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | SUN PHARMACEUTICAL INDUSTRIES, INC. | 63304-110 |
| Guaifenesin and Dextromethorphan Hydrobromide HBRguaifenesin and dextromethorphan hydrobromide | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | RITE-AID | 11822-9996 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | PUBLIX SUPER MARKETS, INC | 41415-998 |
| Mucus Relief - DM Maximum Strengthguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | YYBA CORP | 73581-405 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | PUBLIX SUPER MARKETS, INC | 41415-999 |