Ibuprofen
- Product NDC
- 0615-8311
- 11-digit product format
- 006158311
- Labeler code
- 0615
- Product ID
- 0615-8311_f1acd267-02f3-49a1-b768-2f6f50d76bbd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA078329
- Marketing category
- ANDA
- Marketing start
- 2018-08-24
- Substance
- IBUPROFEN
- Active strength
- 800 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 | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197807 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8311-39 | Ibuprofen | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8311 | IBUPROFEN TABLET, FILM COATED IBUPROFEN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 3 | Current NDC, Legacy NDC, 1 package rows | 20200721_f1842893-7a34-4f77-8231-55fb0c98b22b.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 |
|---|
| 0615-8311-39 | 00615831139 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8311-39) | 2019-07-03 | 0000-00-00 | No | No | Current |