Childrens Ibuprofen Grape
- Product NDC
- 76281-126
- 11-digit product format
- 762810126
- Labeler code
- 76281
- Product ID
- 76281-126_6e18b8d1-3f7b-4d5e-acad-ff3cc38cc310
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- IBUPROFEN
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- AptaPharma Inc.
- Application
- ANDA210602
- Marketing category
- ANDA
- Marketing start
- 2020-09-30
- 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
- Childrens Ibuprofen Grape
- 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 |
|---|
| 76281-126-24 | Childrens Ibuprofen Grape | 1 in 1 CARTON | SUSPENSION | 1 | | 3 |
| 76281-126-24 | Childrens Ibuprofen Grape | 118 mL in 1 BOTTLE | SUSPENSION | 118 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76281-126 | CHILDRENS IBUPROFEN GRAPE (IBUPROFEN) SUSPENSION [APTAPHARMA INC.] | 2 | Current NDC, 2 package rows | 20240214_7caca7e2-6652-45fc-9538-275b43a1594e.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 |
|---|
| 76281-126-24 | 76281012624 | 1 BOTTLE in 1 CARTON (76281-126-24) / 118 mL in 1 BOTTLE | 1 bottle | 2024-01-31 | No | No | Current |