Over-the-counter drug · ANDA
pain reliever fever reducer childrens (Acetaminophen) NDC 0363-0579
Acetaminophen 120 mg/1 · Suppository · Rectal · Walgreen Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-0579-53 | 00363057953 | 12 BLISTER PACK in 1 CARTON (0363-0579-53) / 1 SUPPOSITORY in 1 BLISTER PACKMarketed from Mar 11, 2011 |
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)
- pain reliever fever reducer childrensSuffix: childrens
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 120 mg/1
- Dosage form
- Suppository
- Route
- Rectal
- Labeler
- Walgreen CompanyNDC labeler code 0363
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070607
- Marketing start
- Listing expires
- Identifiers
- Product ID 0363-0579_00ca8084-a5af-4e64-b58a-e8806fe1f101SPL ID 00ca8084-a5af-4e64-b58a-e8806fe1f101SPL set ID f2085b26-5778-4656-8de3-9edd83f914ddRxCUI 198434UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N400363057953followed by a unit qualifier and the quantityPackage 00363-0579-53. 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 • reduces fever • relieves minor aches, pains, and headache
Excerpt only. Read the full label for complete information.
About NDC 0363-0579
- What is NDC 0363-0579?
- 0363-0579 is the product NDC for pain reliever fever reducer childrens, Acetaminophen 120 mg/1 suppository, listed with the FDA by Walgreen Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- pain reliever fever reducer childrens (Acetaminophen).
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- Walgreen Company, 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 pain reliever fever reducer childrens?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 070607
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 for childrenacetaminophen | Acetaminophen 120 mg/1 | SuppositoryRectal | Proficient Rx LP | 63187-373 |
| acetaminophen for childrenacetaminophen | Acetaminophen 120 mg/1 | SuppositoryRectal | NuCare Pharmaceutiacals,Inc. | 68071-4151 |
| acetaminophen for childrenacetaminophen | Acetaminophen 120 mg/1 | SuppositoryRectal | NuCare Pharmaceuticals,Inc. | 68071-4172 |
| fever reducing childrensacetaminophen | Acetaminophen 120 mg/1 | SuppositoryRectal | CVS Pharmacy | 59779-579 |
| Foster and Thrive Pain Relieveracetaminophen | Acetaminophen 120 mg/1 | SuppositoryRectal | Strategic Sourcing Services LLC | 70677-1270 |