Over-the-counter drug · ANDA
Ibuprofen Pain Reliever/Fever Reducer (Ibuprofen) NDC 65162-356
Ibuprofen 200 mg/1 · Capsule, Liquid filled · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-356-02 | 65162035602 | 1 BOTTLE in 1 CARTON (65162-356-02) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Mar 29, 2013 | |
| 65162-356-11 | 65162035611 | 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-356-11)Marketed from Mar 29, 2013 | |
| 65162-356-50 | 65162035650 | 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-356-50)Marketed from Mar 29, 2013 | |
| 65162-356-69 | 65162035669 | 1 BOTTLE in 1 CARTON (65162-356-69) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Mar 29, 2013 |
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 Pain Reliever/Fever ReducerSuffix: Pain Reliever/Fever Reducer
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 200 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202300
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 65162-356_53da63da-f301-44dc-902c-2c288304929fSPL ID 53da63da-f301-44dc-902c-2c288304929fSPL set ID 877440fc-3afb-4123-a2e6-5cb48c74413cRxCUI 310964UNII WK2XYI10QMUPC 0365162356021
- 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
N465162035602followed by a unit qualifier and the quantityPackage 65162-0356-02. 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)
INDICATIONS AND USAGE 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.
About NDC 65162-356
- What is NDC 65162-356?
- 65162-356 is the product NDC for Ibuprofen Pain Reliever/Fever Reducer, Ibuprofen 200 mg/1 capsule, liquid filled, listed with the FDA by Amneal Pharmaceuticals LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibuprofen Pain Reliever/Fever Reducer (Ibuprofen).
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 Pain Reliever/Fever Reducer?
- 1 other product NDC are listed under this name. See all Ibuprofen Pain Reliever/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 Pain Reliever/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 Pain Reliever/Fever Reduceribuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Amneal Pharmaceuticals LLC | 65162-770 | 65162-0770-0265162-0770-1165162-0770-50+1 more |
Other NDCs under ANDA 202300
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 | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-830 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | P & L Development, LLC | 59726-123 |
| Ibuprofen Pain Reliever/Fever Reduceribuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Amneal Pharmaceuticals LLC | 65162-770 |