epinephrine

Product NDC: 68083-685
11-digit product format: 680830685
Labeler code: 68083
Product ID: 68083-685_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: 2025-10-02
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

openFDA Listing Details

Product ID: 68083-685_a7f9fba5-54b0-4001-ba9b-86468e159db7
SPL ID: a7f9fba5-54b0-4001-ba9b-86468e159db7
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: epinephrine
Generic name: epinephrine
Dosage form: INJECTION
Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Marketing start: 2025-10-02
Marketing category: ANDA
Application number: ANDA219239
Pharmacologic classes: Adrenergic alpha-Agonists [MoA]; Adrenergic beta-Agonists [MoA]; Catecholamine [EPC]; Catecholamines [CS]; alpha-Adrenergic Agonist [EPC]; beta-Adrenergic Agonist [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
EPINEPHRINE	1 mg/mL

Package NDC	Description	Marketing start	Sample
68083-685-01	1 VIAL, MULTI-DOSE in 1 CARTON (68083-685-01) / 30 mL in 1 VIAL, MULTI-DOSE	2025-10-02	No

UNII	Preferred term	Registry number	Matched term
YKH834O4BH	EPINEPHRINE	51-43-4	EPINEPHRINE

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68083-685-01	68083068501	1 VIAL, MULTI-DOSE in 1 CARTON (68083-685-01) / 30 mL in 1 VIAL, MULTI-DOSE	2025-10-02	No	No	Historical

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