Ibuprofen
- Product NDC
- 68016-635
- 11-digit product format
- 680160635
- Labeler code
- 68016
- Product ID
- 68016-635_6a35618f-26b9-4159-a128-b0ce651fe70d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Chain Drug Consortium
- Application
- ANDA075139
- Marketing category
- ANDA
- Marketing start
- 1999-03-01
- Marketing end
- 2026-07-31
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen
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 |
|---|
| 68016-635-10 | Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 13 |
| 68016-635-10 | Ibuprofen | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 13 |
| 68016-635-50 | Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 13 |
| 68016-635-50 | Ibuprofen | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM] | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM] | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM] | 1 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68016-635 | IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM] | 12 | Current NDC, Legacy NDC, 4 package rows | 20241116_63f270d9-244a-43a0-b472-03137b1f259f.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 |
|---|
| 68016-635-10 | 68016063510 | 1 BOTTLE in 1 CARTON (68016-635-10) / 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 1999-03-01 | 2026-07-31 | No | No | Current |
| 68016-635-50 | 68016063550 | 1 BOTTLE in 1 CARTON (68016-635-50) > 50 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 1999-03-01 | 0000-00-00 | No | No | Current |