ibuprofen pm
- Product NDC
- 42507-050
- 11-digit product format
- 425070050
- Labeler code
- 42507
- Product ID
- 42507-050_574cd550-b66e-4dad-abd8-3330fc429474
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- diphenhydramine citrate, ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- HyVee Inc
- Application
- ANDA079113
- Marketing category
- ANDA
- Marketing start
- 2009-03-02
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ibuprofen pm
- Listing expiration
- 2027-12-31
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 |
|---|
| 42507-050-27 | ibuprofen pm | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 5 |
| 42507-050-58 | ibuprofen pm | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 5 |
| 42507-050-58 | ibuprofen pm | 40 in 1 BOTTLE | TABLET, FILM COATED | 40 | | 5 |
| 42507-050-60 | ibuprofen pm | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 5 |
| 42507-050-60 | ibuprofen pm | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 5 |
| 42507-050-80 | ibuprofen pm | 80 in 1 BOTTLE | TABLET, FILM COATED | 80 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DIPHENHYDRAMINE CITRATE | ACTIVE INGREDIENT | 4OD433S209 | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC] | 2 | |
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC] | 2 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC] | 2 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC] | 2 | |
| GLYCERYL DIBEHENATE | INACTIVE INGREDIENT | R8WTH25YS2 | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC] | 2 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC] | 2 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [HYVEE INC] | 2 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42507-050-27 | 42507005027 | 1 BOTTLE in 1 CARTON (42507-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE (42507-050-80) | 1 bottle | 2009-03-02 | No | No | Historical |
| 42507-050-58 | 42507005058 | 1 in 1 CARTON | | | | | Historical |
| 42507-050-60 | 42507005060 | 20 in 1 BOTTLE | | | | | Historical |
| 42507-050-80 | 42507005080 | 80 in 1 BOTTLE | | | | | Historical |