Flumazenil
- Product NDC
- 0404-9860
- 11-digit product format
- 004049860
- Labeler code
- 0404
- Product ID
- 0404-9860_7ffd4deb-5b2a-4f5a-9fae-fe764f86fcf9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- flumazenil
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Henry Schein, Inc
- Application
- ANDA076755
- Marketing category
- ANDA
- Marketing start
- 2022-01-10
- Marketing end
- 2026-07-31
- Substance
- FLUMAZENIL
- Active strength
- .1 mg/mL
- Pharmacologic classes
- Benzodiazepine Antagonist [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Flumazenil
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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9860-05 | Flumazenil | 1 in 1 BAG | INJECTION | 1 | | 5 |
| 0404-9860-05 | Flumazenil | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION | 5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9860 | FLUMAZENIL INJECTION [HENRY SCHEIN, INC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240529_904f7154-433a-4ea1-b622-acf79568d96b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0404-9860-05 | 00404986005 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9860-05) / 5 mL in 1 VIAL, MULTI-DOSE | 2022-01-10 | 2026-07-31 | No | No | Current |