Ibuprofen
- Product NDC
- 57344-110
- 11-digit product format
- 573440110
- Labeler code
- 57344
- Product ID
- 57344-110_289b7de2-bf15-48ea-e063-6394a90a2f9d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- AAA Pharmaceutical, Inc.
- Application
- ANDA079129
- Marketing category
- ANDA
- Marketing start
- 2014-09-01
- 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 |
|---|
| 57344-110-01 | Ibuprofen | 1 in 1 CARTON | TABLET, COATED | 1 | | 6 |
| 57344-110-01 | Ibuprofen | 24 in 1 BOTTLE, PLASTIC | TABLET, COATED | 24 | | 6 |
| 57344-110-02 | Ibuprofen | 50 in 1 BOTTLE, PLASTIC | TABLET, COATED | 50 | | 6 |
| 57344-110-02 | Ibuprofen | 1 in 1 CARTON | TABLET, COATED | 1 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Ibuprofen | ACTIVE INGREDIENT | WK2XYI10QM | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| Ibuprofen | ACTIVE MOIETY | WK2XYI10QM | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| Carboxymethylcellulose Sodium | INACTIVE INGREDIENT | K679OBS311 | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| dextrose monohydrate | INACTIVE INGREDIENT | LX22YL083G | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| Egg Phospholipids | INACTIVE INGREDIENT | 1Z74184RGV | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| ferric oxide red | INACTIVE INGREDIENT | 1K09F3G675 | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| maltodextrin | INACTIVE INGREDIENT | 7CVR7L4A2D | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| povidone K30 | INACTIVE INGREDIENT | U725QWY32X | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| Sodium Starch Glycolate Type A Corn | INACTIVE INGREDIENT | AG9B65PV6B | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| stearic acid | INACTIVE INGREDIENT | 4ELV7Z65AP | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| triacetin | INACTIVE INGREDIENT | XHX3C3X673 | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57344-110 | IBUPROFEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20241210_39e55ec1-213f-4996-adca-68a5ffbc409b.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 |
|---|
| 57344-110-01 | 57344011001 | 1 BOTTLE, PLASTIC in 1 CARTON (57344-110-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC | 2017-07-01 | 0000-00-00 | No | No | Current |
| 57344-110-02 | 57344011002 | 50 in 1 BOTTLE, PLASTIC | | | | | Historical |