Ibuprofen PM
- Product NDC
- 68016-057
- 11-digit product format
- 680160057
- Labeler code
- 68016
- Product ID
- 68016-057_21afce91-afbe-4b38-a8a5-8775148835e8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- IBUPROFEN, DIPHENHYDRAMINE HCL
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Premier Value Alliance LLC
- Application
- ANDA090397
- Marketing category
- ANDA
- Marketing start
- 2018-10-25
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
- Active strength
- 25; 200 mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 PM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
| IBUPROFEN | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TC2D6JAD40, WK2XYI10QM |
| Rxcui | 901814 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68016-057-40 | Ibuprofen PM | 40 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 40 | | 1 |
| 68016-057-40 | Ibuprofen PM | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68016-057 | IBUPROFEN PM (IBUPROFEN, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [PREMIER VALUE ALLIANCE LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20181107_21afce91-afbe-4b38-a8a5-8775148835e8.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 |
|---|
| 68016-057-40 | 68016005740 | 1 BOTTLE in 1 CARTON (68016-057-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE | 1 bottle | 2018-10-25 | 0000-00-00 | No | No | Current |