Over-the-counter drug · ANDA
8HR Muscle Aches and Pain (Acetaminophen) NDC 57344-201
Acetaminophen 650 mg/1 · Tablet, Extended release · Oral · AAA Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57344-201-03 | 5734402010357344020103 | 1 BOTTLE, PLASTIC in 1 CARTON (57344-201-03) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTICMarketed from Apr 15, 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)
- 8HR Muscle Aches and Pain
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 650 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- AAA Pharmaceutical, Inc.NDC labeler code 57344
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211544
- Marketing start
- Listing expires
- Identifiers
- Product ID 57344-201_1acb85ab-75f3-22cf-e063-6294a90a3434SPL ID 1acb85ab-75f3-22cf-e063-6294a90a3434SPL set ID 15abb899-e301-40e6-e063-6294a90a4bacRxCUI 1148399UNII 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
N457344020103followed by a unit qualifier and the quantityPackage 57344-0201-03. 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 temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 57344-201
- What is NDC 57344-201?
- 57344-201 is the product NDC for 8HR Muscle Aches and Pain (acetaminophen), Acetaminophen 650 mg/1 tablet, extended release, listed with the FDA by AAA Pharmaceutical, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- 8HR Muscle Aches and Pain (Acetaminophen).
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- AAA Pharmaceutical, Inc., NDC labeler code 57344. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for 8HR Muscle Aches and Pain?
- 1 other product NDC are listed under this name. See all 8HR Muscle Aches and Pain NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other 8HR Muscle Aches and Pain products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| 8HR Muscle Aches and Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | FSA STORE INC. | 81522-201 | 81522-0201-03 |
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 |
|---|---|---|---|---|
| Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Grocery Outlet, Inc. | 85828-200 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Bi-Mart | 37835-512 |
| Acetaminophen | Acetaminophen 650 mg/1 | TabletOral | Walgreens | 0363-0892 |
| 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 |
| 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 | 62207-183 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Granules India Limited | 62207-188 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8624 |
| 8 Hour Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-083 |
| 8 Hour Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-082 |
| 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 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-1340 |
| 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 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | WALGREENS | 0363-9992 |
| DOLO - NeuroBion Acetaminophen Max Extended-Release 650 mgacetaminophen | Acetaminophen 650 mg/1 | TabletOral | BENARD INDUSTRIES INC | 55959-179 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Granules India Limited | 62207-892 |
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