Over-the-counter drug · ANDA
Acetaminophen 250 mg and Ibuprofen 125 mg (Acetaminophen and ibuprofen) NDC 43598-052
Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 · Tablet, Film coated · Oral · Dr. Reddy's Labortories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-052-05 | 4359800520543598005205 | 500 TABLET, FILM COATED in 1 BOTTLE (43598-052-05)Marketed from Feb 19, 2025 | |
| 43598-052-14 | 4359800521443598005214 | 144 TABLET, FILM COATED in 1 BOTTLE (43598-052-14)Marketed from Feb 19, 2025 | |
| 43598-052-18 | 4359800521843598005218 | 1 BOTTLE in 1 CARTON (43598-052-18) / 18 TABLET, FILM COATED in 1 BOTTLEMarketed from Feb 19, 2025 | |
| 43598-052-25 | 4359800522543598005225 | 1 BOTTLE in 1 CARTON (43598-052-25) / 250 TABLET, FILM COATED in 1 BOTTLEMarketed from Feb 19, 2025 | |
| 43598-052-95 | 4359800529543598005295 | 250 TABLET, FILM COATED in 1 BOTTLE (43598-052-95)Marketed from Feb 19, 2025 |
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 250 mg and Ibuprofen 125 mg
- Generic name (nonproprietary)
- acetaminophen and ibuprofen
- Active ingredients
- Ibuprofen — 125 mg/1Acetaminophen — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Dr. Reddy's Labortories IncNDC labeler code 43598
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218247
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 43598-052_49a54544-f18b-6461-9ed0-2740e8df4b6cSPL ID 49a54544-f18b-6461-9ed0-2740e8df4b6cSPL set ID 3e65c8a3-498e-1a2a-bb76-18e28ae2c73cRxCUI 2387532UNII WK2XYI10QM, 362O9ITL9D
- 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
N443598005205followed by a unit qualifier and the quantityPackage 43598-0052-05. 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.
About NDC 43598-052
- What is NDC 43598-052?
- 43598-052 is the product NDC for Acetaminophen 250 mg and Ibuprofen 125 mg, Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 tablet, film coated, listed with the FDA by Dr. Reddy's Labortories Inc. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acetaminophen 250 mg and Ibuprofen 125 mg (Acetaminophen and Ibuprofen).
- What is the active ingredient?
- Ibuprofen, Acetaminophen.
- Who is the labeler?
- Dr. Reddy's Labortories Inc, NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acetaminophen 250 mg and Ibuprofen 125 mg?
- 3 other product NDCs are listed under this name. See all Acetaminophen 250 mg and Ibuprofen 125 mg NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Acetaminophen 250 mg and Ibuprofen 125 mg products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Acetaminophen 250 mg and Ibuprofen 125 mgacetaminophen 250 mg and ibuprofen 125 mg tablets | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4258 | 51672-4258-0151672-4258-04 |
| Acetaminophen 250 mg and Ibuprofen 125 mg | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | R J General Corporation | 70264-040 | 70264-0040-12 |
| Acetaminophen 250 mg and Ibuprofen 125 mgacetaminophen 250 mg and ibuprofen 125 mg tablets | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | MARKSANS PHARMA LIMITED | 25000-080 | 25000-0080-0725000-0080-7225000-0080-74 |
Other NDCs under ANDA 218247
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 |
|---|---|---|---|---|
| Dual Actionacetaminophen and ibuprofen (nsaid) tablets, 250 mg/ 125 mg | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc | 75907-158 |