Ibuprofen
- Product NDC
- 36800-348
- 11-digit product format
- 368000348
- Labeler code
- 36800
- Product ID
- 36800-348_c46f0761-169a-4f2e-9db2-4426c003c935
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- TOP CARE (Topco Associates LLC)
- Application
- ANDA206568
- Marketing category
- ANDA
- Marketing start
- 2019-07-31
- Substance
- IBUPROFEN
- Active strength
- 200 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-348-20 | Ibuprofen | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | | 5 |
| 36800-348-20 | Ibuprofen | 20 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 20 | | 5 |
| 36800-348-80 | Ibuprofen | 80 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 80 | | 5 |
| 36800-348-80 | Ibuprofen | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-348 | IBUPROFEN CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)] | 5 | Current NDC, Legacy NDC, 4 package rows | 20221130_2744cf51-4866-4429-bc5b-25a31790e799.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 36800-348-20 | 36800034820 | 1 BOTTLE, PLASTIC in 1 BOX (36800-348-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC | 2019-07-31 | 0000-00-00 | No | No | Current |
| 36800-348-80 | 36800034880 | 1 BOTTLE, PLASTIC in 1 BOX (36800-348-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC | 2019-07-31 | 0000-00-00 | No | No | Current |