Over-the-counter drug · ANDA
Acetaminophen NDC 68196-935
Acetaminophen 650 mg/1 · Tablet · Oral · SAM'S WEST INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68196-935-20 | 6819609352068196093520 | 200 TABLET in 1 BOTTLE (68196-935-20)Marketed from Dec 28, 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)
- Acetaminophen
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 650 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- SAM'S WEST INCNDC labeler code 68196
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211544
- Marketing start
- Listing expires
- Identifiers
- Product ID 68196-935_4653bc49-45c1-1753-e063-6394a90aa02fSPL ID 4653bc49-45c1-1753-e063-6394a90aa02fSPL set ID e77c2bc7-0258-4a6d-e053-2a95a90afe6eRxCUI 198444UNII 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
N468196093520followed by a unit qualifier and the quantityPackage 68196-0935-20. 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: 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 68196-935
- What is NDC 68196-935?
- 68196-935 is the product NDC for Acetaminophen, Acetaminophen 650 mg/1 tablet, listed with the FDA by SAM'S WEST INC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acetaminophen.
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- SAM'S WEST INC, NDC labeler code 68196. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acetaminophen?
- 234 other product NDCs are listed under this name. See all Acetaminophen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Acetaminophen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| acetaminophen | Acetaminophen 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4787 | 70518-4787-00 |
| Acetaminophen | Acetaminophen 325 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4782 | 70518-4782-0070518-4782-01 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4783 | 70518-4783-00 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Amazon.com Services LLC | 72288-440 | 72288-0440-09 |
| acetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | Amazon.com Services LLC | 72288-150 | 72288-0150-79 |
| Acetaminophen | Acetaminophen 10 mg/mL | Injection, SolutionIntravenous | Somerset Therapeutics, LLC | 70069-871 | 70069-0871-10 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Walgreens | 0363-9810 | 00363-9810-1000363-9810-2500363-9810-50+1 more |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | PUBLIX SUPERMARKETS, INC | 41415-175 | 41415-0175-0541415-0175-10 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Family Dollar, Inc. | 55319-751 | 55319-0751-24 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Meijer Distribution Inc | 79481-0780 | 79481-0780-0179481-0780-0279481-0780-04 |
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 |
| 8HR Muscle Aches and Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | AAA Pharmaceutical, Inc. | 57344-201 |
| 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 | 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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