Ibuprofen
- Product NDC
- 46994-291
- 11-digit product format
- 469940291
- Labeler code
- 46994
- Product ID
- 46994-291_30ed48e4-ffe4-4c0c-8b24-61f5b97cbe9c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- SAVE-A-LOT FOOD STORES, LTD.
- Application
- ANDA075010
- Marketing category
- ANDA
- Marketing start
- 1988-05-24
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | IBUPROFEN TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] | 4 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | IBUPROFEN TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | IBUPROFEN TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | IBUPROFEN TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | IBUPROFEN TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] | 4 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | IBUPROFEN TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | IBUPROFEN TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | IBUPROFEN TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] | 4 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | IBUPROFEN TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46994-291 | IBUPROFEN TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.] | 15 | Legacy NDC | 20240816_26c9452e-de42-4b2e-9e4b-bfc0e2735c83.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 46994-291-12 | 46994029112 | 1 BOTTLE, PLASTIC in 1 CARTON (46994-291-12) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 1988-05-24 | 0000-00-00 | No | No | Current |