Home NDC 0548-5850 Glucagon
Product NDC 0548-5850
11-digit product format 005485850
Labeler code 0548
Product ID 0548-5850_7b1b15a9-4632-4749-b4ad-95dd0c5d3966
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glucagon
Dosage form KIT
Labeler Amphastar Pharmaceuticals, Inc.
Application ANDA208086
Marketing category ANDA
Marketing start 2021-02-10
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 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 A208086-001 GLUCAGON GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RS 2020-12-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208086-001 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 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RS 2020-12-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RS 2020-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RS 2020-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RS 2020-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RS 2020-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RS 2020-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RS 2020-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RS 2020-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RS 2020-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RS 2020-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RS 2020-12-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RS 2020-12-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RS 2020-12-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RS 2020-12-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RS 2020-12-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2020-12-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2020-12-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2020-12-28 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2020-12-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2020-12-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2020-12-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2020-12-28 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RS 2020-12-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RS 2020-12-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RS 2020-12-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION RS 2020-12-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2020-12-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2020-12-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2020-12-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2020-12-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2020-12-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2020-12-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2020-12-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2020-12-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP 2020-12-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208086-001 GLUCAGON 1MG/VIAL INJECTABLE / INJECTION AP RS 2020-12-28 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Glucagon
Listing expiration 2027-12-31 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 0548-5850-00 Glucagon 1 in 1 KIT KIT 1 3 0548-5905-00 Glucagon 1 mL in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 mL 1 mg in 1mL 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0548-5850 GLUCAGON KIT [AMPHASTAR PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20210211_8cc40354-b5ac-45b6-a211-93b44444f2a3.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0548-5850-00 00548585000 1 KIT in 1 KIT (0548-5850-00) * 1 mL in 1 VIAL (0548-5905-00) * 1 mL in 1 SYRINGE (0548-5831-00) 1 kit 2021-02-10 0000-00-00 No No Current 0548-5905-00 00548590500 1 mL in 1 VIAL 1 ml Historical