Ibuprofen
- Product NDC
- 36800-440
- 11-digit product format
- 368000440
- Labeler code
- 36800
- Product ID
- 36800-440_a15041f7-99a8-4b99-8bbc-727bb7554d3d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA206568
- Marketing category
- ANDA
- Marketing start
- 2018-05-30
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 310964 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-440-29 | Ibuprofen | 180 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 180 | | 2 |
| 36800-440-80 | Ibuprofen | 2 in 1 PACKAGE | CAPSULE, LIQUID FILLED | 2 | | 2 |
| 36800-440-80 | Ibuprofen | 180 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 180 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-440 | IBUPROFEN CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC] | 2 | Current NDC, Legacy NDC, 3 package rows | 20190312_4aef9935-2e36-4779-a8a8-5288060573af.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 36800-440-29 | 36800044029 | 180 CAPSULE, LIQUID FILLED in 1 BOTTLE (36800-440-29) | | 2018-05-30 | 0000-00-00 | No | No | Current |
| 36800-440-80 | 36800044080 | 2 BOTTLE in 1 PACKAGE (36800-440-80) / 180 CAPSULE, LIQUID FILLED in 1 BOTTLE | 2 bottle | 2018-05-30 | 0000-00-00 | No | No | Current |