Ibuprofen
- Product NDC
- 35916-0989
- 11-digit product format
- 359160989
- Labeler code
- 35916
- Product ID
- 35916-0989_495880e2-c219-84bd-e063-6294a90a645a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Softgel Healthcare Private Limited
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-01-10
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen
- Listing expiration
- 2027-12-31
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 |
|---|
| 35916-0989-1 | Ibuprofen | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | | 2 |
| 35916-0989-1 | Ibuprofen | 1000 in 1 BAG | CAPSULE, LIQUID FILLED | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 35916-0989 | IBUPROFEN CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PRIVATE LIMITED] | 1 | Current NDC, 2 package rows | 20250112_2b07ace6-6766-0a06-e063-6294a90ad1bd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 35916-0989-1 | 35916098901 | 1 BAG in 1 BOX (35916-0989-1) / 1000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2025-01-10 | No | No | Current |