Home NDC 0548-8352 Baqsimi
Product NDC 0548-8352
11-digit product format 005488352
Labeler code 0548
Product ID 0548-8352_8d3aa4dd-737c-49b4-af0d-fe95e3bee54d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glucagon
Dosage form POWDER
Route NASAL
Labeler Amphastar Pharmaceuticals, Inc.
Application NDA210134
Marketing category NDA
Marketing start 2019-07-24
Substance GLUCAGON
Active strength 3 mg/1
Pharmacologic classes Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]
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 N210134-001 BAQSIMI GLUCAGON 3MG POWDER / NASAL RLD, RS 2019-07-24
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210134-001 10213487 2036-02-16 U-2604 Drug product 2019-08-23 N210134-001 12370241 2036-02-16 U-2604 Drug product 2025-11-14 N210134-001 10765602 2039-09-23 Drug product 2020-10-08
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N210134-001 NPP 2028-03-17
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 · 41 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 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210134-001 BAQSIMI 3MG POWDER / NASAL RLD, RS 2019-07-24 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 4 · 131 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N210134-001 10213487 2036-02-16 U-2604 Drug product 2019-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210134-001 12370241 2036-02-16 U-2604 Drug product 2025-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210134-001 10765602 2039-09-23 Drug product 2020-10-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210134-001 10213487 2036-02-16 U-2604 Drug product 2019-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210134-001 12370241 2036-02-16 U-2604 Drug product 2025-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210134-001 10765602 2039-09-23 Drug product 2020-10-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210134-001 10213487 2036-02-16 U-2604 Drug product 2019-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210134-001 12370241 2036-02-16 U-2604 Drug product 2025-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210134-001 10765602 2039-09-23 Drug product 2020-10-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210134-001 10213487 2036-02-16 U-2604 Drug product 2019-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210134-001 10765602 2039-09-23 Drug product 2020-10-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210134-001 10213487 2036-02-16 U-2604 Drug product 2019-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210134-001 10894133 2038-01-03 Drug product 2021-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210134-001 10765602 2039-09-23 Drug product 2020-10-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210134-001 10213487 2036-02-16 U-2604 Drug product 2019-08-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210134-001 10894133 2038-01-03 Drug product 2021-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210134-001 10765602 2039-09-23 Drug product 2020-10-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210134-001 10213487 2036-02-16 U-2604 Drug product 2019-08-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210134-001 10894133 2038-01-03 Drug product 2021-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210134-001 10765602 2039-09-23 Drug product 2020-10-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210134-001 10213487 2036-02-16 U-2604 Drug product 2019-08-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210134-001 10894133 2038-01-03 Drug product 2021-02-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210134-001 10765602 2039-09-23 Drug product 2020-10-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210134-001 10213487 2036-02-16 U-2604 Drug product 2019-08-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210134-001 10894133 2038-01-03 Drug product 2021-02-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210134-001 10765602 2039-09-23 Drug product 2020-10-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210134-001 10213487 2036-02-16 U-2604 Drug product 2019-08-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210134-001 10894133 2038-01-03 Drug product 2021-02-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210134-001 10765602 2039-09-23 Drug product 2020-10-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210134-001 10213487 2036-02-16 U-2604 Drug product 2019-08-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210134-001 10894133 2038-01-03 Drug product 2021-02-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210134-001 10765602 2039-09-23 Drug product 2020-10-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210134-001 10213487 2036-02-16 U-2604 Drug product 2019-08-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210134-001 10894133 2038-01-03 Drug product 2021-02-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210134-001 10765602 2039-09-23 Drug product 2020-10-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210134-001 10213487 2036-02-16 U-2604 Drug product 2019-08-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210134-001 10894133 2038-01-03 Drug product 2021-02-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210134-001 10765602 2039-09-23 Drug product 2020-10-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210134-001 10213487 2036-02-16 U-2604 Drug product 2019-08-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210134-001 10894133 2038-01-03 Drug product 2021-02-10 1e350fbaab3a…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Baqsimi
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLUCAGON 3 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 76LA80IG2G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2180666 Internal RxNorm lookup 2180671 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 0548-8352-02 Baqsimi 2 in 1 CARTON POWDER 2 6 0548-8352-02 Baqsimi 1 in 1 TUBE POWDER 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0548-8352 BAQSIMI (GLUCAGON) POWDER [AMPHASTAR PHARMACEUTICALS, INC.] 5 Current NDC, 2 package rows 20240711_f1f5df9b-872f-44e5-a18f-f0b68e7e9254.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 0548-8352-02 00548835202 2 TUBE in 1 CARTON (0548-8352-02) / 1 BOTTLE, UNIT-DOSE in 1 TUBE / 1 POWDER in 1 BOTTLE, UNIT-DOSE 2 tube 2024-02-07 No No Current