ibuprofen
- Product NDC
- 42507-461
- 11-digit product format
- 425070461
- Labeler code
- 42507
- Product ID
- 42507-461_b2295ddf-f7d7-4fdb-8864-aa9dfebb3f4f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- HyVee Inc
- Application
- ANDA076359
- Marketing category
- ANDA
- Marketing start
- 2005-02-12
- Substance
- IBUPROFEN
- Active strength
- 100 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ibuprofen
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 310963 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42507-461-24 | ibuprofen | 24 in 1 BOTTLE | TABLET, CHEWABLE | 24 | | 3 |
| 42507-461-62 | ibuprofen | 1 in 1 CARTON | TABLET, CHEWABLE | 1 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | IBUPROFEN TABLET, CHEWABLE [HYVEE INC] | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | IBUPROFEN TABLET, CHEWABLE [HYVEE INC] | 1 | |
| ACESULFAME POTASSIUM | INACTIVE INGREDIENT | 23OV73Q5G9 | IBUPROFEN TABLET, CHEWABLE [HYVEE INC] | 1 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | IBUPROFEN TABLET, CHEWABLE [HYVEE INC] | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | IBUPROFEN TABLET, CHEWABLE [HYVEE INC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | IBUPROFEN TABLET, CHEWABLE [HYVEE INC] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | IBUPROFEN TABLET, CHEWABLE [HYVEE INC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | IBUPROFEN TABLET, CHEWABLE [HYVEE INC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | IBUPROFEN TABLET, CHEWABLE [HYVEE INC] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | IBUPROFEN TABLET, CHEWABLE [HYVEE INC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IBUPROFEN TABLET, CHEWABLE [HYVEE INC] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | IBUPROFEN TABLET, CHEWABLE [HYVEE INC] | 1 | |
| SOYBEAN OIL | INACTIVE INGREDIENT | 241ATL177A | IBUPROFEN TABLET, CHEWABLE [HYVEE INC] | 1 | |
| SUCCINIC ACID | INACTIVE INGREDIENT | AB6MNQ6J6L | IBUPROFEN TABLET, CHEWABLE [HYVEE INC] | 1 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42507-461-24 | 42507046124 | 24 in 1 BOTTLE | | | | | Historical |
| 42507-461-62 | 42507046162 | 1 BOTTLE in 1 CARTON (42507-461-62) / 24 TABLET, CHEWABLE in 1 BOTTLE (42507-461-24) | 1 bottle | 2005-02-12 | No | No | Historical |