Over-the-counter drug · ANDA
Pain Relief (Arthritis) NDC 53942-461
Acetaminophen 650 mg/1 · Tablet, Film coated, Extended release · Oral · Demoulas Super Markets, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53942-461-01 | 5394204610153942046101 | 1 BOTTLE in 1 CARTON (53942-461-01) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLEMarketed from Oct 30, 2024 |
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)
- Pain Relief (Arthritis)
- Generic name (nonproprietary)
- pain relief (arthritis)
- Active ingredients
- Acetaminophen — 650 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Demoulas Super Markets, Inc.NDC labeler code 53942
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211544
- Marketing start
- Listing expires
- Identifiers
- Product ID 53942-461_d3dbe7c1-87fd-4359-8d4e-b677bc67b81cSPL ID d3dbe7c1-87fd-4359-8d4e-b677bc67b81cSPL set ID 14a2abd2-0e64-4a8b-a979-cc19a3dbd525UNII 362O9ITL9D
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
N453942046101followed by a unit qualifier and the quantityPackage 53942-0461-01. 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)
Use(s) • temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • premenstrual and menstrual cramps • the common cold • headache • toothache • temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 53942-461
- What is NDC 53942-461?
- 53942-461 is the product NDC for Pain Relief (Arthritis), Acetaminophen 650 mg/1 tablet, film coated, 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?
- Pain Relief (Arthritis).
- What is the active ingredient?
- Acetaminophen.
- 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 Pain Relief (Arthritis)?
- 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 211544
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 |
|---|---|---|---|---|
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Bi-Mart | 37835-512 |
| Arthritis Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | TOPCO ASSOCIATES LLC | 36800-632 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | CVS PHARMACY iNC | 69842-297 |
| Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | AAA Pharmaceutical, Inc. | 57344-200 |
| 8HR Muscle Aches and Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | AAA Pharmaceutical, Inc. | 57344-201 |
| 8 Hour Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-082 |
| 8 Hour Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-083 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | WALGREENS | 0363-9992 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | CVS PHARMACY INC | 69842-322 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Granules India Limited | 62207-188 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Granules India Limited | 62207-183 |
| Acetaminophen | Acetaminophen 650 mg/1 | TabletOral | MAJOR PHARMACEUTICALS | 0904-7314 |
| Acetaminophen | Acetaminophen 650 mg/1 | TabletOral | SAM'S WEST INC | 68196-935 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-160 |
| 8HR Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Demoulas Super Markets, Inc | 53942-200 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | WAL-MART STORES INC | 49035-181 |
| GoodMeds Acetaminophen Extended Releaseacetaminophen extended release | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Cabinet Health P.B.C. | 82725-4054 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-1340 |
| DOLO - NeuroBion Acetaminophen Max Extended-Release 650 mgacetaminophen | Acetaminophen 650 mg/1 | TabletOral | BENARD INDUSTRIES INC | 55959-179 |
| Acetaminophen | Acetaminophen 650 mg/1 | TabletOral | LEADER/ Cardinal Health 110, Inc | 70000-0626 |
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