Home NDC 70748-311 GLUCAGON
Product NDC 70748-311
11-digit product format 707480311
Labeler code 70748
Product ID 70748-311_b5736871-464e-4a9e-8317-610f3c3ca28b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name GLUCAGON
Dosage form KIT
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA214457
Marketing category ANDA
Marketing start 2025-08-04
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 44 .
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 A214457-001 GLUCAGON GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2025-07-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214457-001 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 2026-10-15 13:18:30 2026-09 A214457-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2025-07-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 A214457-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2025-07-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214457-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2025-07-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214457-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2025-07-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214457-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2025-07-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214457-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2025-07-22 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214457-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2025-07-22 a50c72e98297…
Observed Orange Book normalized TE history# 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 GLUCAGON
Listing expiration 2027-12-31 DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70748-309-01 GLUCAGON 1 mL in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 mL 1 mg in 1mL 4 70748-311-01 GLUCAGON 1 in 1 CARTON KIT 1 4
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70748-309-01 70748030901 1 mL in 1 VIAL 1 ml Historical 70748-311-01 70748031101 1 KIT in 1 CARTON (70748-311-01) * 1 mL in 1 VIAL (70748-309-01) * 1 mL in 1 SYRINGE (70748-310-01) 1 kit 2025-08-04 No No Current