Home NDC 68462-760 epinephrine
Product NDC 68462-760
11-digit product format 684620760
Labeler code 68462
Product ID 68462-760_8d5f102d-e131-4a66-980b-6c1f531cf466
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name epinephrine
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler GLENMARK PHARMACEUTICALS INC., USA
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219239-001 EPINEPHRINE EPINEPHRINE 10MG/10ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2025-02-06 A219239-002 EPINEPHRINE EPINEPHRINE 30MG/30ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2025-10-02 A219239-003 EPINEPHRINE EPINEPHRINE 1MG/ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2026-09-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-11-14 07:37:17 2026-10 A219239-001 EPINEPHRINE 10MG/10ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2025-02-06 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A219239-002 EPINEPHRINE 30MG/30ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2025-10-02 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A219239-003 EPINEPHRINE 1MG/ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2026-09-22 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A219239-001 EPINEPHRINE 10MG/10ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2025-02-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219239-002 EPINEPHRINE 30MG/30ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2025-10-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219239-003 EPINEPHRINE 1MG/ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2026-09-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 A219239-001 EPINEPHRINE 10MG/10ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2025-02-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219239-002 EPINEPHRINE 30MG/30ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2025-10-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219239-001 EPINEPHRINE 10MG/10ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2025-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219239-002 EPINEPHRINE 30MG/30ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2025-10-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219239-001 EPINEPHRINE 10MG/10ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2025-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219239-002 EPINEPHRINE 30MG/30ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2025-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219239-001 EPINEPHRINE 10MG/10ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2025-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219239-002 EPINEPHRINE 30MG/30ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2025-10-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219239-001 EPINEPHRINE 10MG/10ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2025-02-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219239-001 EPINEPHRINE 10MG/10ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAOCULAR, SUBCUTANEOUS AP 2025-02-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219239-001 EPINEPHRINE 10MG/10ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAOCULAR, SUBCUTANEOUS AP 2025-02-06 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219239-001 EPINEPHRINE 10MG/10ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2025-02-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219239-002 EPINEPHRINE 30MG/30ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2025-10-02 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219239-001 CGT 2025-09-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219239-001 CGT 2025-09-03 6a471c1ec25d…
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
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YKH834O4BH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310132 Internal RxNorm lookup 1660014 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68462-760-10 epinephrine 1 in 1 CARTON INJECTION 1 2 68462-760-10 epinephrine 10 mL in 1 VIAL, MULTI-DOSE INJECTION 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-760 EPINEPHRINE INJECTION [GLENMARK PHARMACEUTICALS INC., USA] 1 Current NDC, 2 package rows 20250228_cc4ebb51-6020-4339-a36a-ec2380b7d28e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68462-760-10 68462076010 1 VIAL, MULTI-DOSE in 1 CARTON (68462-760-10) / 10 mL in 1 VIAL, MULTI-DOSE 2025-02-06 No No Current