Direct Safety Ibuprofen
- Product NDC
- 61245-085
- 11-digit product format
- 612450085
- Labeler code
- 61245
- Product ID
- 61245-085_3e5d63ea-c1b9-f7fc-e063-6394a90ae253
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Conney Safety Products, LLC
- Application
- ANDA075010
- Marketing category
- ANDA
- Marketing start
- 2016-02-01
- 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
- Direct Safety 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 |
|---|
| 61245-085-13 | Direct Safety Ibuprofen | 250 in 1 BOX | TABLET, COATED | 250 | | 8 |
| 61245-085-13 | Direct Safety Ibuprofen | 2 in 1 PACKET | TABLET, COATED | 2 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61245-085 | DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240117_28d45743-d298-29db-e054-00144ff8d46c.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 |
|---|
| 61245-085-13 | 61245008513 | 250 PACKET in 1 BOX (61245-085-13) / 2 TABLET, COATED in 1 PACKET | 250 packet | 2016-02-01 | 0000-00-00 | No | No | Current |