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.
- 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.
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 | TabletOral | BluePoint Laboratories | 68001-495 |
| Amazon Basic Care Acetaminophenacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Amazon.com Services LLC | 72288-698 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 30142-157 |
| Acetaminophen | Acetaminophen 650 mg/1 | TabletOral | American Health Packaging | 60687-924 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-730 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Better Living Brands, LLC | 21130-108 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy, Inc. | 69842-037 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | WALMART INC. | 79903-132 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy, Inc. | 69842-635 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-848 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-873 |