Ibuprofen PM
- Product NDC
- 36800-756
- 11-digit product format
- 368000756
- Labeler code
- 36800
- Product ID
- 36800-756_297ebb27-968b-44e8-9318-511c73adacfc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- IBUPROFEN, DIPHENHYDRAMINE HCL
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- TOP CARE (Topco Associates LLC)
- Application
- ANDA200888
- Marketing category
- ANDA
- Marketing start
- 2018-07-31
- Marketing end
- 2026-12-31
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen PM
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 |
|---|
| 36800-756-40 | Ibuprofen PM | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | | 4 |
| 36800-756-40 | Ibuprofen PM | 40 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 40 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-756 | IBUPROFEN PM (IBUPROFEN, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)] | 3 | Current NDC, Legacy NDC, 2 package rows | 20221130_7af82ca5-ea36-4b72-88b8-0fe68348d269.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 |
|---|
| 36800-756-40 | 36800075640 | 1 BOTTLE, PLASTIC in 1 BOX (36800-756-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC | 2018-07-31 | 2026-12-31 | No | No | Current |