Over-the-counter drug · ANDA
Topco Mucus Relief (Guaifenesin) NDC 36800-226
Guaifenesin 600 mg/1 · Tablet, Extended release · Oral · Topco Associates, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-226-16 | 3680002261636800022616 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (36800-226-16)Marketed from Jun 1, 2021 |
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)
- Topco Mucus Relief
- Generic name (nonproprietary)
- guaifenesin
- Active ingredients
- Guaifenesin — 600 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Topco Associates, LLCNDC labeler code 36800
- 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 36800-226_201dbdbd-483f-46ee-8db2-e540d0b5cb9dSPL ID 201dbdbd-483f-46ee-8db2-e540d0b5cb9dSPL set ID 03c17c06-6919-4ef4-9d0a-4c039940c671RxCUI 636522UNII 495W7451VQUPC 0036800483880
- 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
N436800022616followed by a unit qualifier and the quantityPackage 36800-0226-16. 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 36800-226
- What is NDC 36800-226?
- 36800-226 is the product NDC for Topco Mucus Relief (guaifenesin), Guaifenesin 600 mg/1 tablet, extended release, listed with the FDA by Topco Associates, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Topco Mucus Relief (Guaifenesin).
- What is the active ingredient?
- Guaifenesin.
- Who is the labeler?
- Topco Associates, LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Topco Mucus Relief?
- 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 |
| Mucus Relief Maximum Strength 1200 mgguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Guardian Drug Company | 53041-191 |