ibuprofen
- Product NDC
- 45802-897
- 11-digit product format
- 458020897
- Labeler code
- 45802
- Product ID
- 45802-897_f3294bf5-78b1-4945-b2fe-8e508bc4b429
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA074937
- Marketing category
- ANDA
- Marketing start
- 2011-11-17
- 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
- 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 | 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 |
|---|
| 45802-897-26 | ibuprofen | 118 mL in 1 BOTTLE | SUSPENSION | 118 | | 6 |
| 45802-897-26 | ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | | 6 |
| 45802-897-34 | ibuprofen | 237 mL in 1 BOTTLE | SUSPENSION | 237 | | 6 |
| 45802-897-34 | ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45802-897 | IBUPROFEN SUSPENSION [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 6 | Current NDC, Legacy NDC, 4 package rows | 20250305_02889717-204c-463b-8506-4c5cf18c77d3.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 |
|---|
| 45802-897-26 | 45802089726 | 1 BOTTLE in 1 CARTON (45802-897-26) / 118 mL in 1 BOTTLE | 1 bottle | 2011-11-17 | 0000-00-00 | No | No | Current |
| 45802-897-34 | 45802089734 | 1 BOTTLE in 1 CARTON (45802-897-34) / 237 mL in 1 BOTTLE | 1 bottle | 2014-04-09 | 0000-00-00 | No | No | Current |