Ibuprofen
- Product NDC
- 55319-136
- 11-digit product format
- 553190136
- Labeler code
- 55319
- Product ID
- 55319-136_ea710bfa-eee3-4284-9b18-2533771276e6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Family Dollar (FAMILY WELLNESS)
- Application
- ANDA079129
- Marketing category
- ANDA
- Marketing start
- 2023-08-31
- Substance
- IBUPROFEN
- Active strength
- 200 mg/1
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 310965 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55319-136-05 | Ibuprofen | 500 in 1 BOTTLE, PLASTIC | TABLET, COATED | 500 | | 3 |
| 55319-136-24 | Ibuprofen | 1 in 1 BOX | TABLET, COATED | 1 | | 3 |
| 55319-136-24 | Ibuprofen | 24 in 1 BOTTLE, PLASTIC | TABLET, COATED | 24 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55319-136 | IBUPROFEN TABLET, COATED [FAMILY DOLLAR (FAMILY WELLNESS)] | 3 | Current NDC, 3 package rows | 20230831_eaa0a286-a0f0-4979-8af3-c5f4194283fd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 55319-136-05 | 55319013605 | 500 TABLET, COATED in 1 BOTTLE, PLASTIC (55319-136-05) | 2023-08-31 | No | No | Current |
| 55319-136-24 | 55319013624 | 1 BOTTLE, PLASTIC in 1 BOX (55319-136-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC | 2023-08-31 | No | No | Current |