Ibuprofen
- Product NDC
- 53345-014
- 11-digit product format
- 533450014
- Labeler code
- 53345
- Product ID
- 53345-014_3cd90bef-d64d-4fb5-97db-2cd0a72c9098
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
- Application
- ANDA206568
- Marketing category
- ANDA
- Marketing start
- 2016-10-06
- 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 | 310964 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53345-014-01 | Ibuprofen | 10000 in 1 BAG | CAPSULE, LIQUID FILLED | 10000 | | 3 |
| 53345-014-01 | Ibuprofen | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | | 3 |
| 53345-014-02 | Ibuprofen | 20 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 20 | | 2 |
| 53345-014-02 | Ibuprofen | 35 in 1 BOX | CAPSULE, LIQUID FILLED | 35 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53345-014 | IBUPROFEN CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD] | 3 | Current NDC, Legacy NDC, 2 package rows | 20191123_50bab3b2-f710-46ff-96cd-1ec4d4658529.zip |
| 53345-014 | IBUPROFEN CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD] | 2 | Current NDC, Legacy NDC, 2 package rows | 20191123_58bff8bf-5a4e-4390-9c03-e266d31deb6b.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 |
|---|
| 53345-014-01 | 53345001401 | 1 BAG in 1 BOX (53345-014-01) / 10000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2016-10-06 | 0000-00-00 | No | No | Current |
| 53345-014-02 | 53345001402 | 35 BOTTLE in 1 BOX (53345-014-02) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE | 35 bottle | 2017-07-13 | 0000-00-00 | No | No | Current |