Flumazenil
- Product NDC
- 63323-424
- 11-digit product format
- 633230424
- Labeler code
- 63323
- Product ID
- 63323-424_9f9520ae-2135-4731-8fb2-8a0a771c302b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FLUMAZENIL
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA076955
- Marketing category
- ANDA
- Marketing start
- 2005-04-05
- 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 |
|---|
| 63323-424-01 | Flumazenil | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 5 | | 5 |
| 63323-424-05 | Flumazenil | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | | 5 |
| 63323-424-10 | Flumazenil | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
| 63323-424-10 | Flumazenil | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FLUMAZENIL | ACTIVE INGREDIENT | 40P7XK9392 | FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| FLUMAZENIL | ACTIVE MOIETY | 40P7XK9392 | FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-424 | FLUMAZENIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 5 | Current NDC, Legacy NDC, 4 package rows | 20250416_a72d9fc1-121c-455d-93a9-002378c9968f.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 |
|---|
| 63323-424-01 | 63323042401 | 5 mL in 1 VIAL, MULTI-DOSE | 5 ml | | | | | Historical |
| 63323-424-05 | 63323042405 | 10 VIAL, MULTI-DOSE in 1 TRAY (63323-424-05) / 5 mL in 1 VIAL, MULTI-DOSE (63323-424-01) | | 2005-04-05 | 0000-00-00 | No | No | Current |
| 63323-424-10 | 63323042410 | 1 VIAL, MULTI-DOSE in 1 CARTON (63323-424-10) / 10 mL in 1 VIAL, MULTI-DOSE | | 2005-04-05 | 0000-00-00 | No | No | Current |