Renflexis
- Product NDC
- 78206-162
- 11-digit product format
- 782060162
- Labeler code
- 78206
- Product ID
- 78206-162_ae5aa866-45c5-4dd8-ace4-cabe72994604
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- infliximab
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Organon LLC
- Application
- BLA761054
- Marketing category
- BLA
- Marketing start
- 2017-04-21
- Substance
- INFLIXIMAB
- Active strength
- 100 mg/1
- Pharmacologic classes
- Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Renflexis
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INFLIXIMAB | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | B72HH48FLU |
| Rxcui | 1927285, 1927290 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 78206-162-01 | Renflexis | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 6 |
| 78206-162-99 | Renflexis | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 78206-162 | RENFLEXIS (INFLIXIMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ORGANON LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240110_dbf738c4-3fac-4422-a9d8-51d9c83a8789.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 |
|---|
| 78206-162-01 | 78206016201 | 1 VIAL in 1 CARTON (78206-162-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (78206-162-99) | 1 vial | 2021-06-01 | 0000-00-00 | No | No | Current |
| 78206-162-99 | 78206016299 | 1 in 1 VIAL | | | | | | Historical |