Ibuprofen
- Product NDC
- 55319-893
- 11-digit product format
- 553190893
- Labeler code
- 55319
- Product ID
- 55319-893_0fbe2798-c951-4b30-91e0-437de5ec8c00
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Family Dollar Services Inc
- Application
- ANDA075139
- Marketing category
- ANDA
- Marketing start
- 2023-12-13
- 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 |
|---|
| 55319-893-12 | Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 3 |
| 55319-893-12 | Ibuprofen | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55319-893 | IBUPROFEN TABLET, FILM COATED [FAMILY DOLLAR SERVICES INC] | 2 | Current NDC, 2 package rows | 20241115_89ed9311-2185-4660-b219-9ea67b1a71ec.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 55319-893-12 | 55319089312 | 1 BOTTLE, PLASTIC in 1 CARTON (55319-893-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2023-12-13 | No | No | Current |