Flumazenil
- Product NDC
- 0143-9684
- 11-digit product format
- 001439684
- Labeler code
- 0143
- Product ID
- 0143-9684_0ecaa504-add6-48df-817f-e5d5eef9fc8b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Flumazenil
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA078527
- Marketing category
- ANDA
- Marketing start
- 2009-03-23
- 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 |
|---|
| 0143-9684-01 | Flumazenil | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 5 | | 9 |
| 0143-9684-10 | Flumazenil | 10 in 1 BOX | INJECTION, SOLUTION | 10 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FLUMAZENIL | ACTIVE INGREDIENT | 40P7XK9392 | FLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 4 | |
| FLUMAZENIL | ACTIVE MOIETY | 40P7XK9392 | FLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 4 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | FLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 4 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | FLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 4 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | FLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 4 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | FLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 4 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | FLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 4 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | FLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 4 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | FLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9684 | FLUMAZENIL INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240622_436f5616-9626-4b6a-9deb-2986444179d0.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 |
|---|
| 0143-9684-01 | 00143968401 | 5 mL in 1 VIAL, MULTI-DOSE | 5 ml | | | | | Historical |
| 0143-9684-10 | 00143968410 | 10 VIAL, MULTI-DOSE in 1 BOX (0143-9684-10) / 5 mL in 1 VIAL, MULTI-DOSE (0143-9684-01) | | 2009-03-23 | 0000-00-00 | No | No | Current |