Over-the-counter drug · ANDA
Mucus Relief DM Extended Release Caplets (Guaifenesin, dextromethorphan hbr) NDC 0536-1161
Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 · Tablet, Extended release · Oral · Rugby Laboratories
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0536-1161Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00536-1161Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-1161-34 | 0053611613400536116134 | 20 BLISTER PACK in 1 CARTON (0536-1161-34) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 13, 2018 | |
| 0536-1161-37 | 0053611613700536116137 | 40 BLISTER PACK in 1 CARTON (0536-1161-37) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 13, 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 DM Extended Release Caplets
- Generic name (nonproprietary)
- guaifenesin, dextromethorphan hbr
- Active ingredients
- Guaifenesin — 600 mg/1Dextromethorphan hydrobromide — 30 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Rugby LaboratoriesNDC labeler code 0536
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209692
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0536-1161_f6b72325-a048-4e79-ac83-aa61ae564f81SPL ID f6b72325-a048-4e79-ac83-aa61ae564f81SPL set ID 69cd399a-0103-4543-bb06-c7cccffe9cc4RxCUI 1298324UNII 495W7451VQ, 9D2RTI9KYHUPC 0305361161378
- Pharmacologic class
- Expectorant; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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
N400536116134followed by a unit qualifier and the quantityPackage 00536-1161-34. 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 temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep
Excerpt only. Read the full label for complete information.
About NDC 0536-1161
- What is NDC 0536-1161?
- 0536-1161 is the product NDC for Mucus Relief DM Extended Release Caplets, Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 tablet, extended release, listed with the FDA by Rugby Laboratories. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mucus Relief DM Extended Release Caplets (Guaifenesin, Dextromethorphan HBr).
- What is the active ingredient?
- Guaifenesin, Dextromethorphan hydrobromide.
- Who is the labeler?
- Rugby Laboratories, NDC labeler code 0536. 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 DM Extended Release Caplets?
- 6 other product NDCs are listed under this name. See all Mucus Relief DM Extended Release Caplets 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 DM Extended Release Caplets 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 DM Extended Release Capletsguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | TabletOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-824 | 49035-0824-28 |
| Mucus Relief DM Extended Release Capletsguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | Walgreens | 0363-0733 | 00363-0733-2000363-0733-40 |
| Mucus Relief DM Extended Release Capletsguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | TabletOral | QUALITY CHOICE (Chain Drug Marketing Association) | 63868-870 | 63868-0870-14 |
| Mucus Relief DM Extended Release Capletsguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | TabletOral | Cardinal Health (Leader) 70000 | 70000-0464 | 70000-0464-0170000-0464-02 |
| Mucus Relief DM Extended Release Capletsguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | ATLANTIC BIOLOGICALS CORP. | 17856-1162 | 17856-1162-01 |
| Mucus Relief DM Extended Release Capletsguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | TabletOral | A-S Medication Solutions | 50090-6020 | 50090-6020-00 |
Other NDCs under ANDA 209692
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 and Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-038 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-039 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | Rite Aid Corporation | 11822-0733 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | H E B | 37808-730 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | H E B | 37808-733 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | H E B | 37808-834 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Family Dollar (FAMILY WELLNESS) | 55319-734 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Family Dollar (FAMILY WELLNESS) | 55319-741 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-733 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | P & L Development, LLC | 59726-733 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | Best Choice (Valu Merchandisers Company) | 63941-733 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | TabletOral | Best Choice (Valu Merchandisers Company) | 63941-734 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | WinCo Foods, LLC | 67091-344 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1049 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1050 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | Care One (Retail Business Services, LLC.) | 72476-733 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | TabletOral | Care One (Retail Business Services, LLC.) | 72476-734 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | FSA Store Inc. (Caring Mills) | 81522-734 |
| Mucus Relief DMguaifenesin dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-137 |
| Mucus Relief DM Extended Release Capletsguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | Walgreens | 0363-0733 |
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