Ibuprofen
- Product NDC
- 64380-809
- 11-digit product format
- 643800809
- Labeler code
- 64380
- Product ID
- 64380-809_e19243fc-3b9e-4de9-8874-1a6eb683efe8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA078329
- Marketing category
- ANDA
- Marketing start
- 2018-08-24
- Substance
- IBUPROFEN
- Active strength
- 400 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 | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197805, 197806, 197807 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64380-809-06 | Ibuprofen | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 13 |
| 64380-809-07 | Ibuprofen | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-809 | IBUPROFEN TABLET, FILM COATED [STRIDES PHARMA SCIENCE LIMITED] | 12 | Current NDC, Legacy NDC, 2 package rows | 20250325_a266a3c6-932f-476f-ae93-48a785c92286.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64380-809-06 | 64380080906 | 100 TABLET, FILM COATED in 1 BOTTLE (64380-809-06) | 2018-12-10 | 0000-00-00 | No | No | Current |
| 64380-809-07 | 64380080907 | 500 TABLET, FILM COATED in 1 BOTTLE (64380-809-07) | 2018-08-24 | 0000-00-00 | No | No | Current |