Over-the-counter drug · ANDA
Ibuprofen NDC 57344-109
Ibuprofen 200 mg/1 · Tablet, Coated · Oral · AAA Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57344-109-03 | 57344010903 | 1 BOTTLE, PLASTIC in 1 CARTON (57344-109-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Oct 1, 2012 | |
| 57344-109-05 | 57344010905 | 500 TABLET, COATED in 1 BOTTLE, PLASTIC (57344-109-05)Marketed from May 1, 2019 |
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
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 200 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- AAA Pharmaceutical, Inc.
- 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 57344-109_458c094e-5757-0b4a-e063-6394a90aa3f9SPL ID 458c094e-5757-0b4a-e063-6394a90aa3f9SPL set ID fbc7fb61-d295-464b-9f3b-52262ed6f31aRxCUI 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
N457344010903followed by a unit qualifier and the quantityPackage 57344-0109-03. 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: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever
Excerpt only. Read the full label for complete information.
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 |
|---|---|---|---|---|
| GoodMeds Ibuprofen 200mgibuprofen 200mg | Ibuprofen 200 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-4029 |
| CVS Ibuprofenibuprofen | Ibuprofen 200 mg/1 | TabletOral | CVS Pharmacy | 51316-187 |
| Ibuprofen, Circle K, 50ctibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Lil' Drug Store Products, Inc. | 66715-5607 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Pioneer Life Sciences, LLC | 72090-070 |
| RIGHT REMEDIES Ibuprofen 200 MGibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Strive Pharmaceuticals Inc. | 70692-179 |
| 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 |
| Ibuprofen, Lil Drug Store, 24ctibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Lil' Drug Store Products, Inc. | 66715-6739 |
| Ibuprofen, Lil Drug Store, 50ctibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Lil' Drug Store Products, Inc. | 66715-6720 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Family Dollar (FAMILY WELLNESS) | 55319-137 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Family Dollar (FAMILY WELLNESS) | 55319-136 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | P & L Development, LLC | 59726-003 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Family Dollar (FAMILY WELLNESS) | 55319-252 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | P & L Development, LLC | 59726-139 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Strategic Sourcing Services, LLC | 70677-1244 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | NUVICARE LLC | 84324-038 |
| Flex-Prinibuprofen | Ibuprofen 200 mg/1 | TabletOral | Provision Medical Products | 69103-2525 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | AAA Pharmaceutical, Inc. | 57344-110 |
| IBUPROFEN Immediate Releaseibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Strides Pharma Inc | 59556-857 |
| IBUPROFEN Immediate Releaseibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Strides Pharma Inc | 59556-858 |