Over-the-counter drug · ANDA
Guaifenesin 600 mg NDC 25000-042
Guaifenesin 600 mg/1 · Tablet · Oral · MARKSANS PHARMA LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25000-042-01 | 2500000420125000004201 | 1 BOTTLE in 1 CARTON (25000-042-01) / 20 TABLET in 1 BOTTLEMarketed from Aug 23, 2023 | |
| 25000-042-12 | 2500000421225000004212 | 500 TABLET in 1 BOTTLE (25000-042-12)Marketed from Aug 23, 2023 | |
| 25000-042-55 | 2500000425525000004255 | 2 BLISTER PACK in 1 CARTON (25000-042-55) / 10 TABLET in 1 BLISTER PACKMarketed from Aug 23, 2023 | |
| 25000-042-99 | 2500000429925000004299 | 2 BLISTER PACK in 1 CARTON (25000-042-99) / 20 TABLET in 1 BLISTER PACKMarketed from Apr 18, 2025 |
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 600 mg
- Active ingredients
- Guaifenesin — 600 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- MARKSANS PHARMA LIMITEDNDC labeler code 25000
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217780
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 25000-042_0af3bdb4-c1f3-4941-a1de-6e08c49849cbSPL ID 0af3bdb4-c1f3-4941-a1de-6e08c49849cbSPL set ID fedf43d0-d6d1-4f50-bbab-396701e45cb2RxCUI 310621, 636522UNII 495W7451VQUPC 0325000042127, 0325000041120, 0325000042554, 0325000041342, 0325000041755, 0325000042011, 0325000042998
- 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
N425000004201followed by a unit qualifier and the quantityPackage 25000-0042-01. 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)
INDICATIONS & USAGE SECTION 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 25000-042
- What is NDC 25000-042?
- 25000-042 is the product NDC for Guaifenesin 600 mg, Guaifenesin 600 mg/1 tablet, listed with the FDA by MARKSANS PHARMA LIMITED. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Guaifenesin 600 mg.
- What is the active ingredient?
- Guaifenesin.
- Who is the labeler?
- MARKSANS PHARMA LIMITED, NDC labeler code 25000. 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 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 | CVS Pharmacy | 51316-008 | 51316-0008-01 |
| 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 217780
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 1200 mg/1 | Tablet, Extended releaseOral | BJWC (Berkley & Jensen / BJ's) | 68391-724 |
| Maximum Strength Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | SAM'S WEST INC | 68196-033 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Grocery Outlet, Inc. | 85828-723 |
| Mucus Relief ERguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Rugby Laboratories | 0536-1249 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy | 51316-724 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 41226-723 |
| Maximum Strength Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 41226-724 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | LEADER/ Cardinal Health 110, Inc. | 70000-0730 |
| Guaifenesin Extended Release 600 mgguaifenesin | Guaifenesin 600 mg/1 | TabletOral | TIME CAP LABORATORIES, INC. | 49483-723 |
| Guaifenesin Extended Release 1200 mgguaifenesin | Guaifenesin 1200 mg/1 | TabletOral | TIME CAP LABORATORIES, INC. | 49483-724 |
| Guaifenesin 1200 mg | Guaifenesin 1200 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-041 |