Renflexis
- Product NDC
- 0006-4305
- 11-digit product format
- 000064305
- Labeler code
- 0006
- Product ID
- 0006-4305_30c59fed-f54d-4d12-bf5f-495429b14dda
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- infliximab
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Merck Sharp & Dohme Corp.
- Application
- BLA761054
- Marketing category
- BLA
- Marketing start
- 2017-07-01
- Marketing end
- 0000-00-00
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 0006-4305-02 | 2025-01-30 | C162847 | 48780-1 | f386c649-e6fb-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use RENFLEXIS safely and effectively. See full prescribing information for RENFLEXIS. RENFLEXIS (infliximab-abda) for injection, for intravenous use Initial U.S. Approval: 2017 RENFLEXIS (infliximab-abda) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differe |
| 0006-4305-02 | 2023-02-03 | C162847 | 48780-1 | f386c649-e6fb-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use RENFLEXIS safely and effectively. See full prescribing information for RENFLEXIS. RENFLEXIS (infliximab-abda) for injection, for intravenous use Initial U.S. Approval: 2017 RENFLEXIS (infliximab-abda) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differe |
| 0006-4305-02 | 2023-01-30 | C162847 | 48780-1 | f386c649-e6fb-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use RENFLEXIS safely and effectively. See full prescribing information for RENFLEXIS. RENFLEXIS (infliximab-abda) for injection, for intravenous use Initial U.S. Approval: 2017 RENFLEXIS (infliximab-abda) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differe |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0006-4305-01 | Renflexis | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 14 |
| 0006-4305-02 | Renflexis | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0006-4305 | RENFLEXIS (INFLIXIMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC] | 14 | Legacy NDC, 2 package rows | 20230204_3827e1be-f328-45f7-b113-311b57039f8c.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 |
|---|
| 0006-4305-01 | 00006430501 | 1 in 1 VIAL | | | | | | Historical |
| 0006-4305-02 | 00006430502 | 1 VIAL in 1 CARTON (0006-4305-02) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0006-4305-01) | 1 vial | 2017-07-01 | 0000-00-00 | No | No | Current |