FLUMAZENIL
- Product NDC
- 0404-9793
- 11-digit product format
- 004049793
- Labeler code
- 0404
- Product ID
- 0404-9793_bd300433-4b66-48b5-bd42-4b311b701907
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- flumazenil
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA078527
- Marketing category
- ANDA
- Marketing start
- 2025-02-14
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9793-05 | FLUMAZENIL | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 1 |
| 0404-9793-05 | FLUMAZENIL | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9793 | FLUMAZENIL INJECTION, SOLUTION [HENRY SCHEIN, INC.] | 1 | Current NDC, 2 package rows | 20250221_1855bb03-392f-4a0d-8361-24fc2a0e635e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0404-9793-05 | 00404979305 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9793-05) / 5 mL in 1 VIAL, MULTI-DOSE | 2025-02-14 | No | No | Historical |