Ibuprofen
- Product NDC
- 64380-997
- 11-digit product format
- 643800997
- Labeler code
- 64380
- Product ID
- 64380-997_5f919f0a-7dad-405f-b383-dcde4091b5ec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA215311
- Marketing category
- ANDA
- Marketing start
- 2023-09-19
- Substance
- IBUPROFEN
- Active strength
- 100 mg/5mL
- 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 | 100 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197803 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64380-997-01 | Ibuprofen | 5 mL in 1 CUP | SUSPENSION | 5 | | 7 |
| 64380-997-02 | Ibuprofen | 10 in 1 TRAY | SUSPENSION | 10 | | 7 |
| 64380-997-03 | Ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | | 7 |
| 64380-997-03 | Ibuprofen | 118 mL in 1 BOTTLE | SUSPENSION | 118 | | 7 |
| 64380-997-04 | Ibuprofen | 473 mL in 1 BOTTLE | SUSPENSION | 473 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-997 | IBUPROFEN SUSPENSION [STRIDES PHARMA SCIENCE LIMITED] | 6 | Current NDC, Legacy NDC, 5 package rows | 20231012_38ebacc3-378f-483e-babc-76119677e7df.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 |
|---|
| 64380-997-01 | 64380099701 | 5 mL in 1 CUP | 5 ml | | | | | Historical |
| 64380-997-02 | 64380099702 | 10 in 1 TRAY | | | | | | Historical |
| 64380-997-03 | 64380099703 | 1 BOTTLE in 1 CARTON (64380-997-03) / 118 mL in 1 BOTTLE | 1 bottle | 2023-09-19 | 0000-00-00 | No | No | Current |
| 64380-997-04 | 64380099704 | 473 mL in 1 BOTTLE (64380-997-04) | 473 ml | 2023-09-19 | 0000-00-00 | No | No | Current |