Ibuprofen
- Product NDC
- 63981-393
- 11-digit product format
- 639810393
- Labeler code
- 63981
- Product ID
- 63981-393_a505176d-d118-4a10-885d-1d6e2b884252
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- COSTCO WHOLESALE CORPORATION
- Application
- ANDA075139
- Marketing category
- ANDA
- Marketing start
- 1999-03-01
- Substance
- IBUPROFEN
- Active strength
- 200 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 310965 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63981-393-03 | Ibuprofen | 10 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 10 | | 20 |
| 63981-393-03 | Ibuprofen | 1 in 1 PACKAGE | TABLET, FILM COATED | 1 | | 20 |
| 63981-393-14 | Ibuprofen | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 20 |
| 63981-393-58 | Ibuprofen | 750 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 750 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | IBUPROFEN TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION] | 2 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | IBUPROFEN TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION] | 2 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | IBUPROFEN TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION] | 2 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | IBUPROFEN TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION] | 2 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | IBUPROFEN TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | IBUPROFEN TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION] | 2 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | IBUPROFEN TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | IBUPROFEN TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION] | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | IBUPROFEN TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | IBUPROFEN TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63981-393 | IBUPROFEN TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION] | 19 | Current NDC, Legacy NDC, 4 package rows | 20240825_4b8ad98e-de76-4f49-3b89-01e9dd5cde16.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 |
|---|
| 63981-393-03 | 63981039303 | 1 BOTTLE, PLASTIC in 1 PACKAGE (63981-393-03) > 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 1999-03-01 | 0000-00-00 | Yes | No | Current |
| 63981-393-14 | 63981039314 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63981-393-14) | 1999-03-01 | 0000-00-00 | No | No | Current |
| 63981-393-58 | 63981039358 | 750 in 1 BOTTLE, PLASTIC | | | | | Historical |