Over-the-counter drug · ANDA
Guaifenesin NDC 68196-960
Guaifenesin 1200 mg/1 · Tablet, Extended release · Oral · Sam's West Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68196-960-56 | 6819609605668196096056 | 4 BLISTER PACK in 1 CARTON (68196-960-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 31, 2025 |
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
- Sam's West IncNDC labeler code 68196
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210453
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 68196-960_71ac9d71-8840-4a60-b50d-cbe6dfb53d2eSPL ID 71ac9d71-8840-4a60-b50d-cbe6dfb53d2eSPL set ID 3867a132-1a87-5e08-e063-6294a90a6dc8RxCUI 310621UNII 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
N468196096056followed by a unit qualifier and the quantityPackage 68196-0960-56. 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 68196-960
- What is NDC 68196-960?
- 68196-960 is the product NDC for Guaifenesin, Guaifenesin 1200 mg/1 tablet, extended release, listed with the FDA by Sam's West Inc. It has 1 package NDC, 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?
- Sam's West Inc, NDC labeler code 68196. 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 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 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | GRANULES USA, INC. | 69848-018 | 69848-0018-16 |
Other NDCs under ANDA 210453
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 |
|---|---|---|---|---|
| 365 Whole Foods Market Guaifenesinguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Whole Foods Market, Inc. | 42681-0057 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | WALGREEN CO. | 0363-0028 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | WALGREEN CO. | 0363-0033 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | RITE AID CORPORATION | 11822-4260 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Better Living Brands LLC | 21130-179 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-810 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-811 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-853 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-857 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-864 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-865 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-561 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | VESPYR BRANDS LLC | 71179-002 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | TOPCO ASSOCIATES LLC | 76162-031 |
| Mucus Relief Maxguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Better Living Brands, LLC | 21130-399 |