Over-the-counter drug · ANDA
Guaifenesin 1200 mg (Guaifenesin) NDC 70677-1258
Guaifenesin 1200 mg/1 · Tablet, Extended release · Oral · Strategic Sourcing Services, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70677-1258-1 | 7067712580170677125801 | 1 BLISTER PACK in 1 CARTON (70677-1258-1) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Feb 15, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 1200 mg
- Generic name (nonproprietary)
- guaifenesin
- Active ingredients
- Guaifenesin — 1200 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Strategic Sourcing Services, LLCNDC labeler code 70677
- 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 70677-1258_ef056a34-8314-eb42-2978-51ded05b0082SPL ID ef056a34-8314-eb42-2978-51ded05b0082SPL set ID 469c5f00-1b6c-6fc7-a352-65764ff25d45RxCUI 310621, 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
N470677125801followed by a unit qualifier and the quantityPackage 70677-1258-01. 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 70677-1258
- What is NDC 70677-1258?
- 70677-1258 is the product NDC for Guaifenesin 1200 mg (guaifenesin), Guaifenesin 1200 mg/1 tablet, extended release, listed with the FDA by Strategic Sourcing Services, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Guaifenesin 1200 mg (Guaifenesin).
- What is the active ingredient?
- Guaifenesin.
- Who is the labeler?
- Strategic Sourcing Services, LLC, NDC labeler code 70677. 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 1200 mg?
- 2 other product NDCs are listed under this name. See all Guaifenesin 1200 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 1200 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 1200 mg | Guaifenesin 1200 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-041 | 25000-0041-1225000-0041-3425000-0041-75 |
| Guaifenesin 1200 mgguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Inc. | 43598-108 | 43598-0108-37 |
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 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 | CVS Pharmacy | 51316-008 |
| Guaifenesin 600 mgguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services, LLC | 70677-1257 |