Over-the-counter drug · ANDA
Ibuprofen Immediate Release (ibuprofen) NDC 59556-855
Ibuprofen 200 mg/1 · Tablet, Coated · Oral · Strides Pharma Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59556-855-42 | 59556085542 | 10000 TABLET, COATED in 1 BAG (59556-855-42)Marketed from Mar 18, 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)
- Ibuprofen Immediate ReleaseSuffix: Immediate Release
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 200 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Strides Pharma Inc
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091355
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 59556-855_71d99813-1855-484f-a71b-333fcb701a77SPL ID 71d99813-1855-484f-a71b-333fcb701a77SPL set ID ebcc4da3-d0f6-4e40-99b5-e88310ea4a5bRxCUI 310965UNII WK2XYI10QM
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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
N459556085542followed by a unit qualifier and the quantityPackage 59556-0855-42. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Uses temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091355
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 |
|---|---|---|---|---|
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | NUVICARE LLC | 84324-039 |
| Ibuprofen Immediate Releaseibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Strides Pharma Inc | 59556-856 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Pioneer Life Sciences, LLC | 72090-071 |