Over-the-counter drug · ANDA
IBUPROFEN Immediate Release (Ibuprofen) NDC 59556-858
Ibuprofen 200 mg/1 · Tablet, Coated · Oral · Strides Pharma Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59556-858-42 | 5955608584259556085842 | 10000 TABLET, COATED in 1 BAG (59556-858-42)Marketed from Mar 18, 2022 | |
| 59556-858-43 | 5955608584359556085843 | 30000 TABLET, COATED in 1 BAG (59556-858-43)Marketed from Jun 1, 2023 |
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 IncNDC labeler code 59556
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079129
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 59556-858_429d1cf2-cd25-4622-a9f9-60cede85df5fSPL ID 429d1cf2-cd25-4622-a9f9-60cede85df5fSPL set ID a5dd275f-f388-44ec-8297-74430a742d52RxCUI 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
N459556085842followed by a unit qualifier and the quantityPackage 59556-0858-42. 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.
About NDC 59556-858
- What is NDC 59556-858?
- 59556-858 is the product NDC for IBUPROFEN Immediate Release (ibuprofen), Ibuprofen 200 mg/1 tablet, coated, listed with the FDA by Strides Pharma Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- IBUPROFEN Immediate Release (Ibuprofen).
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- Strides Pharma Inc, NDC labeler code 59556. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for IBUPROFEN Immediate Release?
- 3 other product NDCs are listed under this name. See all IBUPROFEN Immediate Release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other IBUPROFEN Immediate Release products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ibuprofen Immediate Releaseibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Strides Pharma Inc | 59556-855 | 59556-0855-42 |
| Ibuprofen Immediate Releaseibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Strides Pharma Inc | 59556-856 | 59556-0856-42 |
| IBUPROFEN Immediate Releaseibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Strides Pharma Inc | 59556-857 | 59556-0857-4259556-0857-43 |
Other NDCs under ANDA 079129
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, Circle K, 50ctibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Lil' Drug Store Products, Inc. | 66715-5607 |
| IBUPROFEN Immediate Releaseibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Strides Pharma Inc | 59556-857 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | AAA Pharmaceutical, Inc. | 57344-109 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | AAA Pharmaceutical, Inc. | 57344-110 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Strategic Sourcing Services, LLC | 70677-1244 |
| CVS Ibuprofenibuprofen | Ibuprofen 200 mg/1 | TabletOral | CVS Pharmacy | 51316-187 |
| Ibuprofen, Caseys, 50ctibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Lil' Drug Store Products, Inc. | 66715-6407 |
| Ibuprofen Fast relief medicine for painibuprofen 200 mg | Ibuprofen 200 mg/1 | TabletOral | Allegiant Health | 69168-335 |
| GoodMeds Ibuprofen 200mgibuprofen 200mg | Ibuprofen 200 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-4029 |
| RIGHT REMEDIES Ibuprofen 200 MGibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Strive Pharmaceuticals Inc. | 70692-179 |
| Ibuprofen, Lil Drug Store, 50ctibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Lil' Drug Store Products, Inc. | 66715-6720 |
| Ibuprofen, Lil Drug Store, 24ctibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Lil' Drug Store Products, Inc. | 66715-6739 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | P & L Development, LLC | 59726-003 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Pioneer Life Sciences, LLC | 72090-070 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | P & L Development, LLC | 59726-139 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Family Dollar (FAMILY WELLNESS) | 55319-136 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | NUVICARE LLC | 84324-038 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Family Dollar (FAMILY WELLNESS) | 55319-137 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Family Dollar (FAMILY WELLNESS) | 55319-252 |
| Flex-Prinibuprofen | Ibuprofen 200 mg/1 | TabletOral | Provision Medical Products | 69103-2525 |