Over-the-counter drug · ANDA
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mg (Guaifenesin) NDC 55681-301
Guaifenesin 600 mg/1 · Tablet · Oral · TWIN MED LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55681-301-01 | 5568103010155681030101 | 100 TABLET in 1 BOTTLE (55681-301-01)Marketed from Mar 2, 2022 |
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 GUAIFENESIN EXTENDED-RELEASE 600 mgSuffix: GUAIFENESIN EXTENDED-RELEASE 600 mg
- Generic name (nonproprietary)
- guaifenesin
- Active ingredients
- Guaifenesin — 600 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- TWIN MED LLCNDC labeler code 55681
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213420
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 55681-301_4deb799b-66b2-ddb4-e063-6394a90acf05SPL ID 4deb799b-66b2-ddb4-e063-6394a90acf05SPL set ID d9d13c67-51a1-aa79-e053-2995a90abdbbRxCUI 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
N455681030101followed by a unit qualifier and the quantityPackage 55681-0301-01. 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)
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 55681-301
- What is NDC 55681-301?
- 55681-301 is the product NDC for MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mg, Guaifenesin 600 mg/1 tablet, listed with the FDA by TWIN MED LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mg (Guaifenesin).
- What is the active ingredient?
- Guaifenesin.
- Who is the labeler?
- TWIN MED LLC, NDC labeler code 55681. 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 GUAIFENESIN EXTENDED-RELEASE 600 mg?
- 1 other product NDC are listed under this name. See all MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 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 MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 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) |
|---|---|---|---|---|---|
| MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mgguaifenesin | Guaifenesin 600 mg/1 | TabletOral | YYBA CORP | 73581-401 | 73581-0401-0273581-0401-2073581-0401-70 |
Other NDCs under ANDA 213420
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 600 mg/1 | TabletOral | Bi-Mart | 37835-408 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Bi-Mart | 37835-412 |
| Guaifenesin | Guaifenesin 1200 mg/1 | TabletOral | Walgreens | 0363-0570 |
| Guaifenesin | Guaifenesin 600 mg/1 | TabletOral | Walgreens | 0363-9569 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | AAA Pharmaceutical, Inc. | 57344-203 |
| Guaifenesin | Guaifenesin 1200 mg/1 | TabletOral | SAM'S WEST INC | 68196-405 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | CVS PHARMACY, INC | 69842-335 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Advanced Rx LLC | 80513-403 |
| Good Sense Mucus ERguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Multilayer, Extended releaseOral | L. Perrigo Company | 0113-3650 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Advanced Rx LLC | 80513-413 |
| Guaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Granules India Ltd | 62207-569 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Granules India Ltd | 62207-570 |
| Crcle Guaifenesin Extended-Release Tablets, 600 mgguaifenesin extended-release | Guaifenesin 600 mg/1 | TabletOral | Innovus Pharmaceuticals, Inc. | 57483-270 |
| Crcle Guaifensin Extended Release Tablet, 1200 mgguaifensin extended-release | Guaifenesin 1200 mg/1 | TabletOral | Innovus Pharmaceuticals, Inc. | 57483-280 |
| Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-096 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-097 |
| Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Demoulas Super Markets, Inc | 53942-203 |
| Mucus Relief Maximum Strengthguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Demoulas Super Markets, Inc | 53942-204 |
| Maximum Strength Mucus Reliefguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | CHAIN DRUG MARKETING ASSOCIATION INC | 63868-148 |
| Guaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | GRANULES PHARMACEUTICALS INC. | 70010-199 |
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