Home NDC 68083-633 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 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
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2026-02-19 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…
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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310132 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 68083-633-01 epinephrine 1 in 1 CARTON INJECTION 1 5 68083-633-01 epinephrine 10 mL in 1 VIAL, MULTI-DOSE INJECTION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-633 EPINEPHRINE INJECTION [GLAND PHARMA LIMITED] 3 Current NDC, 2 package rows 20250213_79ca73ca-d3c0-40af-9dec-e2f4ce669cda.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table 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 Current