Over-the-counter drug · ANDA
Guaifenesin 600 mg (Guaifenesin) NDC 51316-008
Guaifenesin 600 mg/1 · Tablet, Extended release · Oral · CVS Pharmacy
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-008-01 | 5131600080151316000801 | 5 BLISTER PACK in 1 CARTON (51316-008-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from May 1, 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 600 mg
- Generic name (nonproprietary)
- guaifenesin
- Active ingredients
- Guaifenesin — 600 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- CVS PharmacyNDC labeler code 51316
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215932
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 51316-008_0f020bff-5cb6-4169-5caa-fceeb1f30813SPL ID 0f020bff-5cb6-4169-5caa-fceeb1f30813SPL set ID ed242994-facd-750e-b7e1-2eec42c1f65fRxCUI 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
N451316000801followed by a unit qualifier and the quantityPackage 51316-0008-01. 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)
Use(s) helps loosen phlegum (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 51316-008
- What is NDC 51316-008?
- 51316-008 is the product NDC for Guaifenesin 600 mg (guaifenesin), Guaifenesin 600 mg/1 tablet, extended release, listed with the FDA by CVS Pharmacy. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Guaifenesin 600 mg (Guaifenesin).
- What is the active ingredient?
- Guaifenesin.
- Who is the labeler?
- CVS Pharmacy, NDC labeler code 51316. 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 600 mg?
- 4 other product NDCs are listed under this name. See all Guaifenesin 600 mg NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Guaifenesin 600 mg 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 600 mg | Guaifenesin 600 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-042 | 25000-0042-0125000-0042-1225000-0042-55+1 more |
| Guaifenesin 600 mgguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Inc. | 43598-110 | 43598-0110-01 |
| Guaifenesin 600 mgguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Inc. | 43598-008 | 43598-0008-0143598-0008-40 |
| Guaifenesin 600 mgguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services, LLC | 70677-1257 | 70677-1257-0170677-1257-02 |
Other NDCs under ANDA 215932
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 1200 mgguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Inc. | 43598-108 |
| Guaifenesin 1200 mgguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services, LLC | 70677-1258 |
| Guaifenesin 600 mgguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Inc. | 43598-008 |
| Guaifenesin 600 mgguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Inc. | 43598-110 |
| Guaifenesin 600 mgguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services, LLC | 70677-1257 |