Over-the-counter drug · ANDA
Acetaminophen NDC 0363-9604
Acetaminophen 650 mg/1 · Tablet, Extended release · Oral · WALGREEN CO.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-9604-07 | 00363960407 | 1 BOTTLE in 1 CARTON (0363-9604-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Jul 7, 2021 | |
| 0363-9604-35 | 00363960435 | 1 BOTTLE in 1 CARTON (0363-9604-35) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Jul 7, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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, Extended release
- Route
- Oral
- Labeler
- WALGREEN CO.NDC labeler code 0363
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207229
- Marketing start
- Listing expires
- Identifiers
- Product ID 0363-9604_e6c2e68f-9711-4b57-b72b-ece33e19edc6SPL ID e6c2e68f-9711-4b57-b72b-ece33e19edc6SPL set ID c20d110a-ed5e-aed4-e053-2a95a90a4200RxCUI 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
N400363960407followed by a unit qualifier and the quantityPackage 00363-9604-07. 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 0363-9604
- What is NDC 0363-9604?
- 0363-9604 is the product NDC for Acetaminophen, Acetaminophen 650 mg/1 tablet, extended release, listed with the FDA by WALGREEN CO.. It has 2 package NDCs, 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?
- WALGREEN CO., NDC labeler code 0363. 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?
- 228 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 207229
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 | Better Living Brands, LLC | 21130-108 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 30142-157 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-730 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-848 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-873 |
| Acetaminophen | Acetaminophen 650 mg/1 | TabletOral | American Health Packaging | 60687-924 |
| Acetaminophen | Acetaminophen 650 mg/1 | TabletOral | BluePoint Laboratories | 68001-495 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy, Inc. | 69842-037 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy, Inc. | 69842-635 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | WALMART INC. | 79903-132 |
| Amazon Basic Care Acetaminophenacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Amazon.com Services LLC | 72288-698 |