Assured Ibuprofen
- Product NDC
- 68210-4139
- 11-digit product format
- 682104139
- Labeler code
- 68210
- Product ID
- 68210-4139_28ef5535-36c5-ed54-e063-6394a90aefc6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Spirit Pharmaceuticals LLC
- Application
- ANDA202312
- Marketing category
- ANDA
- Marketing start
- 2019-02-25
- 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
- Assured 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 |
|---|
| 68210-4139-4 | Assured Ibuprofen | 40 in 1 BOTTLE | TABLET, FILM COATED | 40 | | 6 |
| 68210-4139-4 | Assured Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68210-4139 | ASSURED IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241212_119263b5-c3b7-46dc-a3bd-9893bfd24628.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 |
|---|
| 68210-4139-4 | 68210413904 | 1 BOTTLE in 1 CARTON (68210-4139-4) / 40 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2021-04-28 | 0000-00-00 | No | No | Current |