Home Applications 020928 Application 020928
Type NDA
Sponsor LILLY Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GLUCAGON GLUCAGON INJECTABLE;INJECTION 1MG/VIAL Yes 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date N020928-001 GLUCAGON GLUCAGON 1MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1998-09-11
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.
Product history page 1 of 2 · 42 observed 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 N020928-001 GLUCAGON 1MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1998-09-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020928-001 GLUCAGON 1MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1998-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020928-001 GLUCAGON 1MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1998-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020928-001 GLUCAGON 1MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1998-09-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020928-001 GLUCAGON 1MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1998-09-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020928-001 GLUCAGON 1MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1998-09-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020928-001 GLUCAGON 1MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1998-09-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020928-001 GLUCAGON 1MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1998-09-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020928-001 GLUCAGON 1MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1998-09-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020928-001 GLUCAGON 1MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1998-09-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020928-001 GLUCAGON 1MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1998-09-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RLD 1998-09-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RLD 1998-09-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RLD 1998-09-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RLD 1998-09-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1998-09-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1998-09-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1998-09-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RLD, RS 1998-09-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1998-09-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1998-09-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1998-09-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1998-09-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RLD, RS 1998-09-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RLD, RS 1998-09-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RLD, RS 1998-09-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RLD, RS 1998-09-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RLD, RS 1998-09-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RLD 1998-09-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RLD 1998-09-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RLD 1998-09-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RLD 1998-09-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1998-09-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1998-09-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1998-09-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1998-09-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1998-09-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1998-09-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1998-09-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020928-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1998-09-11 e64feba35796…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0002-8031 Glucagon glucagon Eli Lilly and Company NDA Current 0002-8031 Glucagon glucagon Eli Lilly and Company NDA Current 0002-8031 Glucagon glucagon Eli Lilly and Company NDA Current 0002-8031 Glucagon glucagon Eli Lilly and Company NDA Current 0002-8031 Glucagon glucagon Eli Lilly and Company NDA Current 0002-8031 Glucagon glucagon Eli Lilly and Company NDA Current 50090-0639 Glucagon glucagon A-S Medication Solutions NDA Current 63323-582 Glucagon Glucagon Fresenius Kabi USA, LLC NDA Current 64725-8031 Glucagon glucagon TYA Pharmaceuticals NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 66086 SUPPL 2021-02-03 66006 SUPPL 2021-01-27 56965 SUPPL 2018-12-21 54858 SUPPL 2018-07-09 54865 SUPPL 2018-07-06 53764 SUPPL 2018-04-20 53738 SUPPL 2018-04-19 35654 SUPPL 2004-04-05 26211 SUPPL 2004-02-25 41816 ORIG 1998-09-11 26210 ORIG 1998-09-11 13750 ORIG 1998-09-11