Leader Ibuprofen PM
- Product NDC
- 70000-0157
- 11-digit product format
- 700000157
- Labeler code
- 70000
- Product ID
- 70000-0157_3987ffc4-5b9d-465e-a269-5dadb8ce95b2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- diphenhydramine citrate, ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cardinal Health 110, LLC. dba Leader
- Application
- ANDA079113
- Marketing category
- ANDA
- Marketing start
- 2016-11-23
- Substance
- DIPHENHYDRAMINE CITRATE; IBUPROFEN
- Active strength
- 38; 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
- Leader Ibuprofen PM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIPHENHYDRAMINE CITRATE | 38 mg/1 |
| IBUPROFEN | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4OD433S209, WK2XYI10QM |
| Rxcui | 895664 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70000-0157-1 | Leader Ibuprofen PM | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 7 |
| 70000-0157-1 | Leader Ibuprofen PM | 40 in 1 BOTTLE | TABLET, FILM COATED | 40 | | 7 |
| 70000-0157-2 | Leader Ibuprofen PM | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 7 |
| 70000-0157-2 | Leader Ibuprofen PM | 80 in 1 BOTTLE | TABLET, FILM COATED | 80 | | 7 |
| 70000-0157-3 | Leader Ibuprofen PM | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 7 |
| 70000-0157-3 | Leader Ibuprofen PM | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70000-0157 | LEADER IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, FILM COATED [CARDINAL HEALTH 110, LLC. DBA LEADER] | 7 | Current NDC, Legacy NDC, 6 package rows | 20241122_b19ad305-4464-4404-a011-584fa0c08521.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 |
|---|
| 70000-0157-1 | 70000015701 | 1 BOTTLE in 1 CARTON (70000-0157-1) / 40 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2016-11-23 | 0000-00-00 | No | No | Current |
| 70000-0157-2 | 70000015702 | 1 BOTTLE in 1 CARTON (70000-0157-2) > 80 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2016-11-23 | 0000-00-00 | No | No | Current |
| 70000-0157-3 | 70000015703 | 1 BOTTLE in 1 CARTON (70000-0157-3) / 20 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2024-11-21 | | No | No | Historical |