Over-the-counter drug · ANDA
Acetaminophen NDC 70000-0626
Acetaminophen 650 mg/1 · Tablet · Oral · LEADER/ Cardinal Health 110, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0626-1 | 7000006260170000062601 | 100 TABLET in 1 BOTTLE (70000-0626-1)Marketed from Mar 2, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- LEADER/ Cardinal Health 110, IncNDC labeler code 70000
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211544
- Marketing start
- Listing expires
- Identifiers
- Product ID 70000-0626_46532c1b-4ecc-d854-e063-6294a90a35acSPL ID 46532c1b-4ecc-d854-e063-6294a90a35acSPL set ID f5dc335d-d3cf-ba94-e053-2a95a90ac6d3RxCUI 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
N470000062601followed by a unit qualifier and the quantityPackage 70000-0626-01. 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)
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 70000-0626
- What is NDC 70000-0626?
- 70000-0626 is the product NDC for Acetaminophen, Acetaminophen 650 mg/1 tablet, listed with the FDA by LEADER/ Cardinal Health 110, 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?
- LEADER/ Cardinal Health 110, Inc, NDC labeler code 70000. 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?
- 227 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 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 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4132 | 68788-4132-0168788-4132-0268788-4132-03+1 more |
| acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-008 | 87441-0008-01 |
| Acetaminophen | Acetaminophen 160 mg/5mL | SolutionOral | Acetris Pharma Holdings, LLC | 52343-555 | 52343-0555-12 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Granules India Limited | 62207-892 | 62207-0892-4962207-0892-51 |
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 |
| Pain Relief (Arthritis) | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | Demoulas Super Markets, Inc. | 53942-461 |
| DOLO - NeuroBion Acetaminophen Max Extended-Release 650 mgacetaminophen | Acetaminophen 650 mg/1 | TabletOral | BENARD INDUSTRIES INC | 55959-179 |
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