Home NDC 0378-8067 Glucagon
Product NDC 0378-8067
11-digit product format 003788067
Labeler code 0378
Product ID 0378-8067_e1d65360-2785-4308-8a64-5c2c9e812868
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glucagon
Dosage form KIT
Labeler Mylan Pharmaceuticals Inc.
Application ANDA204468
Marketing category ANDA
Marketing start 2025-02-26
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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204468-001 GLUCAGON GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2024-12-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204468-001 AP
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 2026-08-18 06:07:40 2026-07 A204468-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2024-12-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204468-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2024-12-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204468-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2024-12-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204468-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2024-12-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204468-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2024-12-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204468-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2024-12-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204468-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2024-12-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204468-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2024-12-12 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204468-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2024-12-12 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Glucagon
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310497 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 0378-8065-32 Glucagon 1 mL in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 mL 1 mg in 1mL 2 0378-8067-90 Glucagon 1 in 1 KIT KIT 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-8067 GLUCAGON KIT [MYLAN PHARMACEUTICALS INC.] 1 Current NDC, 2 package rows 20250302_15b49500-0aae-4e25-9a1d-709983233cc6.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 Units Marketing start Sample Exclude flag Status 0378-8065-32 00378806532 1 mL in 1 VIAL 1 ml Historical 0378-8067-90 00378806790 1 KIT in 1 KIT (0378-8067-90) * 1 mL in 1 VIAL (0378-8065-32) * 1 mL in 1 SYRINGE (0378-8066-32) 1 kit 2025-02-26 No No Current