Over-the-counter drug · ANDA
Acetaminophen and Ibuprofen NDC 55319-139
Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 · Tablet · Oral · Family Dollar
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55319-139-36 | 55319013936 | 36 TABLET in 1 BOTTLE (55319-139-36)Marketed from Nov 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)
- Acetaminophen and Ibuprofen
- Generic name (nonproprietary)
- acetaminophen and ibuprofen
- Active ingredients
- Acetaminophen — 250 mg/1Ibuprofen — 125 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Family Dollar
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216592
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 55319-139_4654caab-ace3-4fdb-e063-6394a90a0b1bSPL ID 4654caab-ace3-4fdb-e063-6394a90a0b1bSPL set ID fe095058-5ecb-75b3-e053-6394a90afb6cRxCUI 2387532UNII 362O9ITL9D, 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
N455319013936followed by a unit qualifier and the quantityPackage 55319-0139-36. 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 ■ muscular aches ■minor pain of arthritis
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216592
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 and Ibuprofen (NSAID) | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | TabletOral | RETAIL BUSINESS SERVICES,LLC | 72476-131 |
| Acetaminophen and Ibuprofen Back Painacetaminophen and ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-213 |
| Acetaminophen and Ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | LEADER/ Cardinal Health 110, Inc. | 70000-0622 |
| Acetaminophen and Ibuprofen | Acetaminophen 1 mg/1; Ibuprofen 125 mg/1 | TabletOral | CVS | 51316-401 |
| Dual Action Pain Relief | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | CapsuleOral | Allegiant Health | 69168-462 |
| Period Pills by Biikayacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | Kai Squared | 85576-101 |
| Acetaminophen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | RAONBIO CORP | 70038-131 |
| Acetaminophen and Ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-131 |
| Aacetaminophen and Ibuprofenacetaminophen and ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | GRANULES USA, INC. | 69848-588 |
| Acetaminophen and Ibuprofen (NSAID) | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | TabletOral | Wal-Mart Stores Inc. | 79903-931 |
| Acetaminophen and Ibuprofen (NSAID) | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | TabletOral | RITE AID | 11822-1131 |
| Acetaminophen and Ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | RUGBY LABORATORIES | 0536-1376 |
| Acetaminophen and Ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | WALGREENS | 0363-9131 |
| Acetaminophen and Ibuprofen | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | TabletOral | CVS | 51316-131 |
| Acetaminophen and Ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | CVS | 51316-132 |
| Acetaminophen and Ibuprofen | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | TabletOral | WAL-MART STORES INC. | 79903-244 |