Over-the-counter drug · ANDA
Ibuprofen (NSAID) Pain Releiver/ Fever Reducer (Ibuprofen) NDC 53746-142
Ibuprofen 200 mg/1 · Tablet · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53746-142-01 | 53746014201 | 100 TABLET in 1 BOTTLE (53746-142-01)Marketed from Dec 16, 2009 | |
| 53746-142-10 | 53746014210 | 1000 TABLET in 1 BOTTLE (53746-142-10)Marketed from Dec 16, 2009 | |
| 53746-142-24 | 53746014224 | 24 TABLET in 1 BOTTLE (53746-142-24)Marketed from Dec 16, 2009 |
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 (NSAID) Pain Releiver/ Fever ReducerSuffix: (NSAID) Pain Releiver/ Fever Reducer
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals of New York LLCNDC labeler code 53746
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072199
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 53746-142_ef67c08a-fc4f-4e6c-a58f-8ed743b2b6aaSPL ID ef67c08a-fc4f-4e6c-a58f-8ed743b2b6aaSPL set ID a8c6bc4e-1e48-4613-8cbf-8c5cd9d51ad0RxCUI 310965UNII WK2XYI10QMUPC 0353746142245, 0353746144249
- 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
N453746014201followed by a unit qualifier and the quantityPackage 53746-0142-01. 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 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 53746-142
- What is NDC 53746-142?
- 53746-142 is the product NDC for Ibuprofen (NSAID) Pain Releiver/ Fever Reducer, Ibuprofen 200 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibuprofen (NSAID) Pain Releiver/ Fever Reducer (Ibuprofen).
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. 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 (NSAID) Pain Releiver/ Fever Reducer?
- 1 other product NDC are listed under this name. See all Ibuprofen (NSAID) Pain Releiver/ Fever Reducer NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ibuprofen (NSAID) Pain Releiver/ Fever Reducer 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 (NSAID) Pain Releiver/ Fever Reduceribuprofen | Ibuprofen 200 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-144 | 53746-0144-0153746-0144-1053746-0144-24 |
Other NDCs under ANDA 072199
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 (NSAID) Pain Releiver/ Fever Reduceribuprofen | Ibuprofen 200 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-144 |