FLUMAZENIL
- Product NDC
- 51662-1254
- 11-digit product format
- 516621254
- Labeler code
- 51662
- Product ID
- 51662-1254_100d725a-9db5-5dd8-e063-6294a90a0797
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FLUMAZENIL
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- HF Acquisition Co. LLC, DBA HealthFirst
- Application
- ANDA078527
- Marketing category
- ANDA
- Marketing start
- 2018-09-01
- Substance
- FLUMAZENIL
- Active strength
- .1 mg/mL
- Pharmacologic classes
- Benzodiazepine Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FLUMAZENIL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUMAZENIL | .1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 40P7XK9392 |
| Rxcui | 204508 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51662-1254-1 | FLUMAZENIL | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 5 | | 8 |
| 51662-1254-2 | FLUMAZENIL | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 8 |
| 51662-1254-2 | FLUMAZENIL | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 5 | | 8 |
| 51662-1254-3 | FLUMAZENIL | 10 in 1 CASE | INJECTION, SOLUTION | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1254 | FLUMAZENIL INJECTION, SOLUTION [HF ACQUISITION CO. LLC, DBA HEALTHFIRST] | 8 | Current NDC, Legacy NDC, 4 package rows | 20240130_74d007e9-9604-0941-e053-2a91aa0a29c4.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 |
|---|
| 51662-1254-1 | 51662125401 | 5 mL in 1 VIAL, MULTI-DOSE (51662-1254-1) | 5 ml | 2018-09-01 | 0000-00-00 | No | No | Current |
| 51662-1254-2 | 51662125402 | 1 in 1 POUCH | | | | | | Historical |
| 51662-1254-3 | 51662125403 | 10 POUCH in 1 CASE (51662-1254-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1254-2) / 5 mL in 1 VIAL, MULTI-DOSE | 10 pouch | 2018-09-01 | 0000-00-00 | No | No | Current |