Ibuprofen
- Product NDC
- 51013-421
- 11-digit product format
- 510130421
- Labeler code
- 51013
- Product ID
- 51013-421_1f723c4e-6023-4e9a-b1c8-868983ebc837
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- PuraCap Pharmaceutical LLC
- Application
- ANDA206568
- Marketing category
- ANDA
- Marketing start
- 2017-08-29
- 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 | 310964 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51013-421-15 | Ibuprofen | 20 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 20 | | 2 |
| 51013-421-15 | Ibuprofen | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | | 2 |
| 51013-421-25 | Ibuprofen | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | | 2 |
| 51013-421-25 | Ibuprofen | 40 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 40 | | 2 |
| 51013-421-26 | Ibuprofen | 80 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 80 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51013-421 | IBUPROFEN CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] | 2 | Current NDC, Legacy NDC, 5 package rows | 20191211_40501966-419a-4ccd-b7c9-5581cbe47a97.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51013-421-15 | 51013042115 | 1 BOTTLE in 1 CARTON (51013-421-15) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE | 1 bottle | 2017-08-29 | 0000-00-00 | No | No | Current |
| 51013-421-25 | 51013042125 | 1 BOTTLE in 1 CARTON (51013-421-25) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE | 1 bottle | 2017-08-29 | 0000-00-00 | No | No | Current |
| 51013-421-26 | 51013042126 | 80 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-421-26) | | 2017-08-29 | 0000-00-00 | No | No | Current |