Childrens Ibuprofen
- Product NDC
- 61269-763
- 11-digit product format
- 612690763
- Labeler code
- 61269
- Product ID
- 61269-763_6753f88d-6ddc-440b-859c-b6cc3744e954
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ibuprofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- H2-Pharma, LLC
- Application
- ANDA074916
- Marketing category
- ANDA
- Marketing start
- 2021-06-29
- Marketing end
- 2023-05-31
- 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
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61269-763-94 | 61269076394 | 1 BOTTLE in 1 CARTON (61269-763-94) > 118 mL in 1 BOTTLE | 1 bottle | 2021-06-29 | 2023-05-31 | No | No | Current |