Over-the-counter drug · ANDA
Mucus Relief Maximum Strength 1200 mg (Guaifenesin) NDC 53041-191
Guaifenesin 1200 mg/1 · Tablet, Extended release · Oral · Guardian Drug Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53041-191-37 | 5304101913753041019137 | 28 TABLET, EXTENDED RELEASE in 1 BOTTLE (53041-191-37)Marketed from Apr 30, 2024 | |
| 53041-191-48 | 5304101914853041019148 | 4 BLISTER PACK in 1 CARTON (53041-191-48) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 24, 2020 | |
| 53041-191-58 | 5304101915853041019158 | 2 BLISTER PACK in 1 CARTON (53041-191-58) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 24, 2020 | |
| 53041-191-62 | 5304101916253041019162 | 70 TABLET, EXTENDED RELEASE in 1 BOTTLE (53041-191-62)Marketed from Apr 30, 2024 |
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)
- Mucus Relief Maximum Strength 1200 mg
- Generic name (nonproprietary)
- guaifenesin
- Active ingredients
- Guaifenesin — 1200 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Guardian Drug CompanyNDC labeler code 53041
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209215
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 53041-191_2ad8b5c2-9495-4ba0-886b-b5f13484aef1SPL ID 2ad8b5c2-9495-4ba0-886b-b5f13484aef1SPL set ID e7742a43-9066-4e28-a90d-f07c0e18f045RxCUI 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
N453041019137followed by a unit qualifier and the quantityPackage 53041-0191-37. 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 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 53041-191
- What is NDC 53041-191?
- 53041-191 is the product NDC for Mucus Relief Maximum Strength 1200 mg, Guaifenesin 1200 mg/1 tablet, extended release, listed with the FDA by Guardian Drug Company. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mucus Relief Maximum Strength 1200 mg (Guaifenesin).
- What is the active ingredient?
- Guaifenesin.
- Who is the labeler?
- Guardian Drug Company, NDC labeler code 53041. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mucus Relief Maximum Strength 1200 mg?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 209215
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 |
|---|---|---|---|---|
| Equate Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Wal-Mart Stores, Inc. | 49035-284 |
| Foster and Thrive Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1013 |
| Guaifenesin | Guaifenesin 600 mg/1 | TabletOral | YYBA CORP | 73581-400 |
| Guaifenesin Extended Release 600 mgguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Wal-Mart Stores, Inc. | 79903-271 |
| Guaifenesin Extended-Release 1200 mgguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Guardian Drug Company | 53041-234 |
| Guaifenesin Extended-Release 600 mgguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Guardian Drug Company | 53041-233 |
| Maximum Strength Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1320 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8637 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Major Pharmaceuticals | 0904-6986 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Discount Drug Mart, Inc | 53943-233 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | McKesson Corporation dba SKY Packaging | 63739-067 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2642 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-499 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | YYBA Corp | 73581-403 |
| Mucus Relief 600 mgguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Guardian Drug Company | 53041-190 |
| Mucus Relief Maxguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Discount Drug Mart, Inc | 53943-234 |
| Topco Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Topco Associates, LLC | 36800-226 |