Ibuprofen
- Product NDC
- 49483-700
- 11-digit product format
- 494830700
- Labeler code
- 49483
- Product ID
- 49483-700_059cb22f-f6dc-5d03-e063-6294a90a9ec1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- TIME CAP LABORATORIES, INC.
- Application
- ANDA079205
- Marketing category
- ANDA
- Marketing start
- 2023-10-23
- 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 |
|---|
| 49483-700-39 | Ibuprofen | 240 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 240 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49483-700 | IBUPROFEN CAPSULE, LIQUID FILLED [TIME CAP LABORATORIES, INC.] | 1 | Current NDC, 1 package rows | 20231027_059cb22f-f6db-5d03-e063-6294a90a9ec1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 49483-700-39 | 49483070039 | 240 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-700-39) | 2023-10-23 | No | No | Historical |