Over-the-counter drug · ANDA
Mucus Relief ER (Guaifenesin) NDC 0904-6718
Guaifenesin 600 mg/1 · Tablet, Extended release · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6718-39 | 0090467183900904671839 | 100 BLISTER PACK in 1 CARTON (0904-6718-39) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Sep 30, 2018 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 ER
- Generic name (nonproprietary)
- guaifenesin
- Active ingredients
- Guaifenesin — 600 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207342
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 0904-6718_ebcfe516-e74c-4f97-8ade-85cfbadf4f33SPL ID ebcfe516-e74c-4f97-8ade-85cfbadf4f33SPL set ID e5a242bf-3008-4c92-a930-e76f733be5cfRxCUI 636522UNII 495W7451VQUPC 0309046718390
- 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
N400904671839followed by a unit qualifier and the quantityPackage 00904-6718-39. 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)
Uses Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.
Excerpt only. Read the full label for complete information.
About NDC 0904-6718
- What is NDC 0904-6718?
- 0904-6718 is the product NDC for Mucus Relief ER (guaifenesin), Guaifenesin 600 mg/1 tablet, extended release, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mucus Relief ER (Guaifenesin).
- What is the active ingredient?
- Guaifenesin.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. 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 ER?
- 2 other product NDCs are listed under this name. See all Mucus Relief ER NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mucus Relief ER products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mucus Relief ERguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Rugby Laboratories | 0536-1249 | 00536-1249-71 |
| Mucus Relief ERguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Cardinal Health 107, LLC | 55154-4153 | 55154-4153-00 |
Other NDCs under ANDA 207342
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 | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-036 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-037 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Rugby Laboratories | 0536-1392 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | TabletOral | Rite Aid Corporation | 11822-3252 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | H E B | 37808-830 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | TabletOral | H E B | 37808-935 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | TabletOral | United Natural Foods, Inc. dba UNFI | 41163-731 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Family Dollar (FAMILY WELLNESS) | 55319-551 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Family Dollar (FAMILY WELLNESS) | 55319-733 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | TabletOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-739 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | P & L Development, LLC | 59726-237 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | P & L Development, LLC | 59726-734 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | TabletOral | Best Choice (Valu Merchandisers Company) | 63941-731 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | TabletOral | WinCo Foods, LLC | 67091-370 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Harris Teeter, LLC | 69256-731 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1051 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1052 |
| Mucus Relief ERguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Cardinal Health 107, LLC | 55154-4153 |
| Mucus Relief Extended Releaseguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Rugby Laboratories, Inc. | 0536-1163 |
| Mucus Relief Extended Releaseguaifenesin | Guaifenesin 1200 mg/1 | TabletOral | TARGET Corporation | 11673-732 |
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