epinephrine
- Product NDC
- 68083-633
- 11-digit product format
- 680830633
- Labeler code
- 68083
- Product ID
- 68083-633_a7f9fba5-54b0-4001-ba9b-86468e159db7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- epinephrine
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA219239
- Marketing category
- ANDA
- Marketing start
- 2025-02-06
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| YKH834O4BH | EPINEPHRINE | 51-43-4 | EPINEPHRINE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-633-01 | 68083063301 | 1 VIAL, MULTI-DOSE in 1 CARTON (68083-633-01) / 10 mL in 1 VIAL, MULTI-DOSE | 2025-02-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| epinephrine | Gland Pharma Limited | 2025-10-06 | Human Prescription Drug Label | 5 |
| epinephrine | Gland Pharma Limited | 2025-02-10 | Human Prescription Drug Label | 3 |