FLUMAZENIL
- Product NDC
- 51662-1253
- 11-digit product format
- 516621253
- Labeler code
- 51662
- Product ID
- 51662-1253_101e7ca0-b5a1-f122-e063-6394a90a6649
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FLUMAZENIL
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- HF Acquisition Co. LLC, DBA Health First
- Application
- ANDA078527
- Marketing category
- ANDA
- Marketing start
- 2018-08-26
- 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 |
|---|
| 51662-1253-1 | FLUMAZENIL | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 5 |
| 51662-1253-2 | FLUMAZENIL | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 5 |
| 51662-1253-2 | FLUMAZENIL | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 5 |
| 51662-1253-3 | FLUMAZENIL | 10 in 1 CASE | INJECTION, SOLUTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1253 | FLUMAZENIL INJECTION, SOLUTION [HF ACQUISITION CO. LLC, DBA HEALTH FIRST] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240131_744ef484-ef46-8d62-e053-2a91aa0a0c05.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 |
|---|
| 51662-1253-1 | 51662125301 | 10 mL in 1 VIAL, MULTI-DOSE (51662-1253-1) | 10 ml | 2018-08-26 | 0000-00-00 | No | No | Current |
| 51662-1253-2 | 51662125302 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | | | | | Historical |
| 51662-1253-3 | 51662125303 | 10 POUCH in 1 CASE (51662-1253-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1253-2) / 10 mL in 1 VIAL, MULTI-DOSE | 10 pouch | 2022-11-10 | 0000-00-00 | No | No | Current |