epinephrine
- Product NDC
- 68083-701
- 11-digit product format
- 680830701
- Labeler code
- 68083
- Product ID
- 68083-701_cff9d22e-947e-497f-a58b-635e55434623
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- epinephrine
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA220400
- Marketing category
- ANDA
- Marketing start
- 2026-10-26
- 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
- 2027-12-31
- Current FDA listing
- Yes
Source provenance: Browse the complete Orange Book source catalog.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- epinephrine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EPINEPHRINE | 1 mg/mL |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-701-01 | 68083070101 | 1 VIAL in 1 CARTON (68083-701-01) / 30 mL in 1 VIAL | 1 vial | 2026-10-26 | No | No | Current |