ibuprofen
- Product NDC
- 42507-166
- 11-digit product format
- 425070166
- Labeler code
- 42507
- Product ID
- 42507-166_b2317a56-d4e8-45fb-a04e-340ca18d8e5a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- HyVee Inc
- Application
- ANDA074937
- Marketing category
- ANDA
- Marketing start
- 2002-05-13
- 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
- Brand name suffix
- childrens
- 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 |
|---|
| 42507-166-00 | ibuprofenchildrens | 118 mL in 1 BOTTLE | SUSPENSION | 118 | | 7 |
| 42507-166-18 | ibuprofenchildrens | 1 in 1 CARTON | SUSPENSION | 1 | | 7 |
| 42507-166-26 | ibuprofenchildrens | 120 mL in 1 BOTTLE | SUSPENSION | 120 | | 7 |
| 42507-166-26 | ibuprofenchildrens | 1 in 1 CARTON | SUSPENSION | 1 | | 7 |
| 42507-166-28 | ibuprofenchildrens | 148 mL in 1 BOTTLE | SUSPENSION | 148 | | 7 |
| 42507-166-28 | ibuprofenchildrens | 1 in 1 CARTON | SUSPENSION | 1 | | 7 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42507-166-00 | 42507016600 | 118 mL in 1 BOTTLE | 118 ml | | | | Historical |
| 42507-166-18 | 42507016618 | 1 BOTTLE in 1 CARTON (42507-166-18) / 118 mL in 1 BOTTLE (42507-166-00) | 1 bottle | 2026-04-10 | No | No | Historical |
| 42507-166-26 | 42507016626 | 120 mL in 1 BOTTLE | 120 ml | | | | Historical |
| 42507-166-28 | 42507016628 | 148 mL in 1 BOTTLE | 148 ml | | | | Historical |