Over-the-counter drug · ANDA
Guaifenesin and Dextromethorphan HBr NDC 65162-038
Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 · Tablet, Extended release · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)65162-038Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65162-0038Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-038-03 | 6516200380365162003803 | 1 BOTTLE in 1 CARTON (65162-038-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Nov 1, 2018 | |
| 65162-038-06 | 6516200380665162003806 | 1 BOTTLE in 1 CARTON (65162-038-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Nov 1, 2018 | |
| 65162-038-17 | 6516200381765162003817 | 2 BLISTER PACK in 1 CARTON (65162-038-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Nov 1, 2018 |
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 HBr
- Generic name (nonproprietary)
- guaifenesin and dextromethorphan hbr
- Active ingredients
- Guaifenesin — 600 mg/1Dextromethorphan hydrobromide — 30 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209692
- 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 65162-038_5d3150b8-1c7d-4789-a6cc-4f1bd0a5bbeaSPL ID 5d3150b8-1c7d-4789-a6cc-4f1bd0a5bbeaSPL set ID 5760a828-1c28-4272-a7b7-ac98466aa294RxCUI 1298324UNII 495W7451VQ, 9D2RTI9KYHUPC 0365162038170
- 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
N465162003803followed by a unit qualifier and the quantityPackage 65162-0038-03. 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 65162-038
- What is NDC 65162-038?
- 65162-038 is the product NDC for Guaifenesin and Dextromethorphan HBr, Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 tablet, extended release, listed with the FDA by Amneal Pharmaceuticals LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Guaifenesin and Dextromethorphan HBr.
- What is the active ingredient?
- Guaifenesin, Dextromethorphan hydrobromide.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 HBr?
- 26 other product NDCs are listed under this name. See all Guaifenesin and Dextromethorphan HBr 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 HBr 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 HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | TOPCO ASSOCIATES LLC | 76162-032 | 76162-0032-56 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Target Corporation | 11673-267 | 11673-0267-0511673-0267-5711673-0267-60 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 30142-276 | 30142-0276-2030142-0276-40 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 30142-275 | 30142-0275-0530142-0275-14 |
| Guaifenesin and Dextromethorphan HBR | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Inc. | 43598-114 | 43598-0114-0143598-0114-2043598-0114-40 |
| Guaifenesin and Dextromethorphan HBR | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Inc. | 43598-231 | 43598-0231-01 |
| Guaifenesin and Dextromethorphan HBR | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Inc. | 43598-232 | 43598-0232-37 |
| Guaifenesin and Dextromethorphan HBR | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy | 51316-009 | 51316-0009-01 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | VESPYR BRANDS LLC | 71179-011 | 71179-0011-21 |
| Guaifenesin And Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Kroger Company | 30142-948 | 30142-0948-2030142-0948-40 |
Other NDCs under ANDA 209692
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 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-039 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | Rite Aid Corporation | 11822-0733 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | H E B | 37808-730 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | H E B | 37808-733 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | H E B | 37808-834 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Family Dollar (FAMILY WELLNESS) | 55319-734 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Family Dollar (FAMILY WELLNESS) | 55319-741 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-733 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | P & L Development, LLC | 59726-733 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | Best Choice (Valu Merchandisers Company) | 63941-733 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | TabletOral | Best Choice (Valu Merchandisers Company) | 63941-734 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | WinCo Foods, LLC | 67091-344 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1049 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1050 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | Care One (Retail Business Services, LLC.) | 72476-733 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | TabletOral | Care One (Retail Business Services, LLC.) | 72476-734 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | FSA Store Inc. (Caring Mills) | 81522-734 |
| Mucus Relief DMguaifenesin dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-137 |
| Mucus Relief DM Extended Release Capletsguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | Walgreens | 0363-0733 |
| Mucus Relief DM Extended Release Capletsguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Rugby Laboratories | 0536-1161 |
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