Ibuprofen
- Product NDC
- 81522-938
- 11-digit product format
- 815220938
- Labeler code
- 81522
- Product ID
- 81522-938_cd2c189b-67cf-4b65-b618-09e82dd32c78
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- FSA Store Inc. (Caring Mills)
- Application
- ANDA074916
- Marketing category
- ANDA
- Marketing start
- 2022-04-15
- Marketing end
- 2026-08-31
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen
- Brand name suffix
- Childrens
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 |
|---|
| 81522-938-04 | IbuprofenChildrens | 118 mL in 1 BOTTLE | SUSPENSION | 118 | | 2 |
| 81522-938-04 | IbuprofenChildrens | 1 in 1 CARTON | SUSPENSION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81522-938 | IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [FSA STORE INC. (CARING MILLS)] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220430_e304f791-755d-4d11-a9f6-3d46ec84197f.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 |
|---|
| 81522-938-04 | 81522093804 | 1 BOTTLE in 1 CARTON (81522-938-04) / 118 mL in 1 BOTTLE | 1 bottle | 2022-04-15 | 2026-08-31 | No | No | Current |