Over-the-counter drug · ANDA
Guaifenesin NDC 21130-179
Guaifenesin 600 mg/1 · Tablet, Extended release · Oral · Better Living Brands LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21130-179-67 | 2113001796721130017967 | 1 BLISTER PACK in 1 CARTON (21130-179-67) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 15, 2022 |
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 — 600 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Better Living Brands LLCNDC labeler code 21130
- 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 21130-179_449da1ee-474d-477e-843b-39b442501809SPL ID 449da1ee-474d-477e-843b-39b442501809SPL set ID ba6ccfc6-d2f8-56d0-e053-2a95a90af6a8RxCUI 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
N421130017967followed by a unit qualifier and the quantityPackage 21130-0179-67. 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 21130-179
- What is NDC 21130-179?
- 21130-179 is the product NDC for Guaifenesin, Guaifenesin 600 mg/1 tablet, extended release, listed with the FDA by Better Living Brands LLC. 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?
- Better Living Brands LLC, 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 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 | 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 | Sam's West Inc | 68196-960 |
| 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 |