epinephrine
- Product NDC
- 68083-591
- 11-digit product format
- 680830591
- Labeler code
- 68083
- Product ID
- 68083-591_53173df9-7a0c-4eb2-8103-8e6405bc1e7b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- epinephrine
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAMUSCULAR; INTRAOCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA218144
- Marketing category
- ANDA
- Marketing start
- 2025-06-03
- Substance
- EPINEPHRINE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- epinephrine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EPINEPHRINE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YKH834O4BH |
| Rxcui | 1660014 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-591-10 | epinephrine | 10 in 1 BOX | INJECTION, SOLUTION, CONCENTRATE | 10 | | 3 |
| 68083-591-10 | epinephrine | 1 mL in 1 AMPULE | INJECTION, SOLUTION, CONCENTRATE | 1 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-591-10 | 68083059110 | 10 AMPULE in 1 BOX (68083-591-10) / 1 mL in 1 AMPULE | 10 ampule | 2025-06-03 | No | No | Current |