Ibuprofen Oral
- Product NDC
- 70677-1117
- 11-digit product format
- 706771117
- Labeler code
- 70677
- Product ID
- 70677-1117_19df0c73-0b7d-481c-b3c4-63baeef064f6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen Oral
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Strategic Sourcing Services
- Application
- ANDA210602
- Marketing category
- ANDA
- Marketing start
- 2023-08-09
- 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 Oral
- 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 |
|---|
| 70677-1117-1 | Ibuprofen Oral | 118 mL in 1 BOTTLE | SUSPENSION | 118 | | 3 |
| 70677-1117-1 | Ibuprofen Oral | 1 in 1 CARTON | SUSPENSION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70677-1117 | IBUPROFEN ORAL SUSPENSION [STRATEGIC SOURCING SERVICES] | 3 | Current NDC, 2 package rows | 20250316_863f7ce3-b7b9-4c66-b351-5b95dd23dcb4.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 |
|---|
| 70677-1117-1 | 70677111701 | 1 BOTTLE in 1 CARTON (70677-1117-1) / 118 mL in 1 BOTTLE | 1 bottle | 2023-08-09 | No | No | Historical |