Over-the-counter drug · ANDA
Guaifenesin NDC 21130-554
Guaifenesin 1200 mg/1 · Tablet · Oral · Safeway, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21130-554-27 | 2113005542721130055427 | 14 TABLET in 1 BLISTER PACK (21130-554-27)Marketed from Jun 30, 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
- Safeway, IncNDC labeler code 21130
- 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 21130-554_46510bfe-1c72-5f4d-e063-6294a90aa930SPL ID 46510bfe-1c72-5f4d-e063-6294a90aa930SPL set ID f32e5b0f-1fd9-9b33-e053-2995a90a8103RxCUI 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
N421130055427followed by a unit qualifier and the quantityPackage 21130-0554-27. 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 21130-554
- What is NDC 21130-554?
- 21130-554 is the product NDC for Guaifenesin, Guaifenesin 1200 mg/1 tablet, listed with the FDA by Safeway, 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?
- Safeway, Inc, NDC labeler code 21130. 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 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 |
|---|---|---|---|---|
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | TabletOral | Bi-Mart | 37835-408 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Bi-Mart | 37835-412 |
| Guaifenesin | Guaifenesin 1200 mg/1 | TabletOral | Walgreens | 0363-0570 |
| Guaifenesin | Guaifenesin 600 mg/1 | TabletOral | Walgreens | 0363-9569 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | AAA Pharmaceutical, Inc. | 57344-203 |
| Guaifenesin | Guaifenesin 1200 mg/1 | TabletOral | SAM'S WEST INC | 68196-405 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | CVS PHARMACY, INC | 69842-335 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Advanced Rx LLC | 80513-403 |
| Good Sense Mucus ERguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Multilayer, Extended releaseOral | L. Perrigo Company | 0113-3650 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Advanced Rx LLC | 80513-413 |
| 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 |
| 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 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-096 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-097 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Demoulas Super Markets, Inc | 53942-203 |
| Mucus Relief Maximum Strengthguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Demoulas Super Markets, Inc | 53942-204 |
| Maximum Strength Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | CHAIN DRUG MARKETING ASSOCIATION INC | 63868-148 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | GRANULES PHARMACEUTICALS INC. | 70010-199 |
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