Over-the-counter drug · ANDA
Guaifenesin NDC 65162-037
Guaifenesin 1200 mg/1 · Tablet, Extended release · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)65162-037Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65162-0037Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-037-03 | 6516200370365162003703 | 1 BOTTLE in 1 CARTON (65162-037-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Jul 27, 2018 | |
| 65162-037-06 | 6516200370665162003706 | 1 BOTTLE in 1 CARTON (65162-037-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Jul 27, 2018 | |
| 65162-037-28 | 6516200372865162003728 | 2 BLISTER PACK in 1 CARTON (65162-037-28) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 27, 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
- Generic name (nonproprietary)
- guaifenesin
- Active ingredients
- Guaifenesin — 1200 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 207342
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 65162-037_f1b3934b-1fc2-4ce8-9465-e1f031daf9c5SPL ID f1b3934b-1fc2-4ce8-9465-e1f031daf9c5SPL set ID ad67e6fd-a68f-44db-9718-84a2cef86e09RxCUI 310621, 636522UNII 495W7451VQ
- Pharmacologic class
- Expectorant
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
N465162003703followed by a unit qualifier and the quantityPackage 65162-0037-03. 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.
Excerpt only. Read the full label for complete information.
About NDC 65162-037
- What is NDC 65162-037?
- 65162-037 is the product NDC for Guaifenesin, Guaifenesin 1200 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.
- What is the active ingredient?
- Guaifenesin.
- 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?
- 63 other product NDCs are listed under this name. See all Guaifenesin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Guaifenesin 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 | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | INNOVUS PHARMACEUTICALS, INC. | 57483-144 | 57483-0144-28 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-857 | 58602-0857-93 |
| Guaifenesinguaifenesin 400 mg | Guaifenesin 400 mg/1 | TabletOral | Zennova LLC | 81993-002 | 81993-0002-0181993-0002-0281993-0002-03+2 more |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | TOPCO ASSOCIATES LLC | 76162-031 | 76162-0031-56 |
| Guaifenesin | Guaifenesin 600 mg/1 | TabletOral | YYBA CORP | 73581-400 | 73581-0400-0273581-0400-07 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Sam's West Inc | 68196-960 | 68196-0960-56 |
| Guaifenesin | Guaifenesin 100 mg/5mL | LiquidOral | KESIN PHARMA CORPORATION | 81033-102 | 81033-0102-16 |
| Guaifenesin | Guaifenesin 100 mg/5mL | SolutionOral | American Health Packaging | 60687-852 | 60687-0852-17 |
| Guaifenesin | Guaifenesin 200 mg/10mL | SolutionOral | American Health Packaging | 60687-863 | 60687-0863-56 |
| Guaifenesin | Guaifenesin 300 mg/15mL | SolutionOral | American Health Packaging | 60687-874 | 60687-0874-16 |
Other NDCs under ANDA 207342
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 | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-036 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Rugby Laboratories | 0536-1392 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | TabletOral | Rite Aid Corporation | 11822-3252 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | H E B | 37808-830 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | TabletOral | H E B | 37808-935 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | TabletOral | United Natural Foods, Inc. dba UNFI | 41163-731 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Family Dollar (FAMILY WELLNESS) | 55319-551 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Family Dollar (FAMILY WELLNESS) | 55319-733 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | TabletOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-739 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | P & L Development, LLC | 59726-237 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | P & L Development, LLC | 59726-734 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | TabletOral | Best Choice (Valu Merchandisers Company) | 63941-731 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | TabletOral | WinCo Foods, LLC | 67091-370 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Harris Teeter, LLC | 69256-731 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1051 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1052 |
| Mucus Relief ERguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Major Pharmaceuticals | 0904-6718 |
| Mucus Relief ERguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Cardinal Health 107, LLC | 55154-4153 |
| Mucus Relief Extended Releaseguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Rugby Laboratories, Inc. | 0536-1163 |
| Mucus Relief Extended Releaseguaifenesin | Guaifenesin 1200 mg/1 | TabletOral | TARGET Corporation | 11673-732 |
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