Over-the-counter drug · ANDA
Mucus Relief Maximum Strength (Guaifenesin) NDC 53942-204
Guaifenesin 1200 mg/1 · Tablet, Extended release · Oral · Demoulas Super Markets, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53942-204-02 | 5394202040253942020402 | 1 BLISTER PACK in 1 CARTON (53942-204-02) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Oct 1, 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 Maximum StrengthSuffix: Maximum Strength
- Generic name (nonproprietary)
- guaifenesin
- Active ingredients
- Guaifenesin — 1200 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Demoulas Super Markets, IncNDC labeler code 53942
- 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 53942-204_ea23a5a6-3f0f-41bb-e053-2a95a90a1f5cSPL ID ea23a5a6-3f0f-41bb-e053-2a95a90a1f5cSPL set ID e8948cbe-1ecc-490d-e053-2995a90a6ba1RxCUI 310621UNII 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
N453942020402followed by a unit qualifier and the quantityPackage 53942-0204-02. 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 53942-204
- What is NDC 53942-204?
- 53942-204 is the product NDC for Mucus Relief Maximum Strength (guaifenesin), Guaifenesin 1200 mg/1 tablet, extended release, listed with the FDA by Demoulas Super Markets, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mucus Relief Maximum Strength (Guaifenesin).
- What is the active ingredient?
- Guaifenesin.
- Who is the labeler?
- Demoulas Super Markets, Inc, NDC labeler code 53942. 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?
- 4 other product NDCs are listed under this name. See all Mucus Relief Maximum Strength 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 Maximum Strength 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 Maximum Strengthmucus relief | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Allegiant Health | 69168-460 | 69168-0460-3269168-0460-5069168-0460-98 |
| Mucus Relief Maximum Strengthguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | HARRIS TEETER | 72036-204 | 72036-0204-02 |
| Mucus Relief Maximum Strengthguaifenesin | Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | WINCO FOODS, LLC | 67091-404 | 67091-0404-02 |
| Mucus Relief Maximum Strengthguaifenesin | Guaifenesin 1200 mg/1 | TabletOral | Care One (American Sales Company) | 41520-732 | 41520-0732-14 |
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 |
| 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 |
| 12 Hour Mucus Reliefguaifenesin | Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | CHAIN DRUG MARKETING ASSOCIATION INC | 63868-149 |
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