Over-the-counter drug · ANDA
Guaifenesin NDC 68196-405
Guaifenesin 1200 mg/1 · Tablet · Oral · SAM'S WEST INC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)68196-405Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68196-0405Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68196-405-14 | 68196040514 | 56 TABLET in 1 BLISTER PACK (68196-405-14)Marketed from Oct 6, 2023 |
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
- 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 213420
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 68196-405_4653b224-fef8-1541-e063-6394a90a94bdSPL ID 4653b224-fef8-1541-e063-6394a90a94bdSPL set ID 00c40e3b-6962-dfb4-e063-6294a90afec6RxCUI 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
N468196040514followed by a unit qualifier and the quantityPackage 68196-0405-14. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 68196-405
- What is NDC 68196-405?
- 68196-405 is the product NDC for Guaifenesin, Guaifenesin 1200 mg/1 tablet, 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?
- 61 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 | Aurohealth LLC | 58602-857 | 58602-0857-93 |
| Guaifenesinguaifenesin 400 mg | Guaifenesin 200 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 | 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 |
| Guaifenesin | Guaifenesin 600 mg/1 | TabletOral | TARGET CORPORATION | 11673-539 | 11673-0539-02 |
Other NDCs under ANDA 213420
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 |
|---|---|---|---|---|
| 12 Hour Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | CHAIN DRUG MARKETING ASSOCIATION INC | 63868-149 |
| basic care mucus er maxguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Multilayer, Extended releaseOral | Amazon.com Services LLC | 72288-650 |
| berkley and jensen mucus reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Multilayer, Extended releaseOral | BJWC | 68391-000 |
| Betr chest congestion reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Multilayer, Extended releaseOral | Live Betr LLC | 80267-002 |
| Betr remedies chest congestion reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Multilayer, Extended releaseOral | Live Betr LLC | 80267-010 |
| Crcle Guaifenesin Extended-Release Tablets, 600 mgguaifenesin extended-release | Guaifenesin 600 mg/1 | TabletOral | Innovus Pharmaceuticals, Inc. | 57483-270 |
| Crcle Guaifensin Extended Release Tablet, 1200 mgguaifensin extended-release | Guaifenesin 1200 mg/1 | TabletOral | Innovus Pharmaceuticals, Inc. | 57483-280 |
| Curist Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Little Pharma, Inc. | 72559-017 |
| Curist Mucus Relief Maximum Strengthguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Little Pharma, Inc. | 72559-013 |
| dg health mucus er maxguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Multilayer, Extended releaseOral | Dolgencorp Inc | 55910-626 |
| Dr. Simi Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Farmacias De Similares TX LLC | 85786-302 |
| Expectorant Guaifenesin Extended-Releaseguaifenesin | Guaifenesin 1200 mg/1 | TabletOral | YET HEALTH GROUP LLC | 81179-007 |
| Good Sense Mucus ERguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Multilayer, Extended releaseOral | L. Perrigo Company | 0113-3650 |
| Guaifenesin | Guaifenesin 1200 mg/1 | TabletOral | Walgreens | 0363-0570 |
| Guaifenesin | Guaifenesin 600 mg/1 | TabletOral | Walgreens | 0363-9569 |
| Guaifenesin | Guaifenesin 600 mg/1 | TabletOral | TARGET CORPORATION | 11673-539 |
| Guaifenesin | Guaifenesin 1200 mg/1 | TabletOral | TARGET CORPORATION | 11673-840 |
| Guaifenesin | Guaifenesin 1200 mg/1 | TabletOral | Safeway, Inc | 21130-554 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Granules India Ltd | 62207-569 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Granules India Ltd | 62207-570 |
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