Ibuprofen
- Product NDC
- 72789-185
- 11-digit product format
- 727890185
- Labeler code
- 72789
- Product ID
- 72789-185_34178401-0edc-512f-e063-6294a90ab88a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078329
- Marketing category
- ANDA
- Marketing start
- 2020-08-21
- Substance
- IBUPROFEN
- Active strength
- 400 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 | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197805, 197806, 197807 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-185-20 | Ibuprofen | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | | 15 |
| 72789-185-30 | Ibuprofen | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 15 |
| 72789-185-60 | Ibuprofen | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 15 |
| 72789-185-82 | Ibuprofen | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 15 |
| 72789-185-90 | Ibuprofen | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-185 | IBUPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 15 | Current NDC, Legacy NDC, 5 package rows | 20250503_3732defa-67c2-4b84-8a84-4bbc27b6cb24.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72789-185-20 | 72789018520 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-185-20) | 2021-07-06 | 0000-00-00 | No | No | Current |
| 72789-185-30 | 72789018530 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-185-30) | 2021-05-18 | 0000-00-00 | No | No | Current |
| 72789-185-60 | 72789018560 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-185-60) | 2021-05-18 | 0000-00-00 | No | No | Current |
| 72789-185-82 | 72789018582 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-185-82) | 2021-05-11 | 0000-00-00 | No | No | Current |
| 72789-185-90 | 72789018590 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-185-90) | 2021-05-18 | 0000-00-00 | No | No | Current |