Baqsimi

Product NDC
85766-212
11-digit product format
857660212
Labeler code
85766
Product ID
85766-212_54988ebe-c60f-a434-e063-6394a90a20d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glucagon
Dosage form
POWDER
Route
NASAL
Labeler
Sportpharm LLC
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N210134-001BAQSIMIGLUCAGON3MGPOWDER / NASALRLD, RS2019-07-24

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N210134-001102134872036-02-16U-2604Drug product2019-08-23
N210134-001123702412036-02-16U-2604Drug product2025-11-14
N210134-001107656022039-09-23Drug product2020-10-08

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N210134-001NPP2028-03-17

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-2484e616aacf4f…
2026-08-18 06:07:402026-07N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-2487673890dc5c…
2021-03-12 10:30 UTC2021-03N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-243f01610625f2…
2019-09-15 20:21 UTC2019-09N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-24b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-243f0d92c62455…
2023-05-13 08:27 UTC2023-05N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-24053a50430f4f…
2023-01-26 05:58 UTC2023-01N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N210134-001BAQSIMI3MGPOWDER / NASALRLD, RS2019-07-24e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 4 · 134 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N210134-001102134872036-02-16U-2604Drug product2019-08-2384e616aacf4f…
2026-09-14 22:38:342026-08N210134-001123702412036-02-16U-2604Drug product2025-11-1484e616aacf4f…
2026-09-14 22:38:342026-08N210134-001107656022039-09-23Drug product2020-10-0884e616aacf4f…
2026-08-18 06:07:402026-07N210134-001102134872036-02-16U-2604Drug product2019-08-23caaa826d4ba7…
2026-08-18 06:07:402026-07N210134-001123702412036-02-16U-2604Drug product2025-11-14caaa826d4ba7…
2026-08-18 06:07:402026-07N210134-001107656022039-09-23Drug product2020-10-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N210134-001102134872036-02-16U-2604Drug product2019-08-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210134-001123702412036-02-16U-2604Drug product2025-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210134-001107656022039-09-23Drug product2020-10-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210134-001102134872036-02-16U-2604Drug product2019-08-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210134-001123702412036-02-16U-2604Drug product2025-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210134-001107656022039-09-23Drug product2020-10-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N210134-001102134872036-02-16U-2604Drug product2019-08-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210134-001107656022039-09-23Drug product2020-10-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210134-001102134872036-02-16U-2604Drug product2019-08-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210134-001108941332038-01-03Drug product2021-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210134-001107656022039-09-23Drug product2020-10-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210134-001102134872036-02-16U-2604Drug product2019-08-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210134-001108941332038-01-03Drug product2021-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210134-001107656022039-09-23Drug product2020-10-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210134-001102134872036-02-16U-2604Drug product2019-08-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210134-001108941332038-01-03Drug product2021-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210134-001107656022039-09-23Drug product2020-10-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210134-001102134872036-02-16U-2604Drug product2019-08-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210134-001108941332038-01-03Drug product2021-02-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210134-001107656022039-09-23Drug product2020-10-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210134-001102134872036-02-16U-2604Drug product2019-08-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210134-001108941332038-01-03Drug product2021-02-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210134-001107656022039-09-23Drug product2020-10-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210134-001102134872036-02-16U-2604Drug product2019-08-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210134-001108941332038-01-03Drug product2021-02-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210134-001107656022039-09-23Drug product2020-10-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210134-001102134872036-02-16U-2604Drug product2019-08-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N210134-001108941332038-01-03Drug product2021-02-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N210134-001107656022039-09-23Drug product2020-10-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210134-001102134872036-02-16U-2604Drug product2019-08-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210134-001108941332038-01-03Drug product2021-02-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210134-001107656022039-09-23Drug product2020-10-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210134-001102134872036-02-16U-2604Drug product2019-08-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210134-001108941332038-01-03Drug product2021-02-10301d65b070ca…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N210134-001NPP2028-03-1784e616aacf4f…
2026-08-18 06:07:402026-07N210134-001NPP2028-03-17caaa826d4ba7…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210134-001NP2022-07-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N210134-001NP2022-07-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N210134-001NP2022-07-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N210134-001NP2022-07-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N210134-001NP2022-07-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N210134-001NP2022-07-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N210134-001NP2022-07-2487673890dc5c…
2021-03-12 10:30 UTC2021-03N210134-001NP2022-07-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N210134-001NP2022-07-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11N210134-001NP2022-07-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12N210134-001NP2022-07-243f01610625f2…
2019-09-15 20:21 UTC2019-09N210134-001NP2022-07-24b00525d2431f…
2023-01-26 05:58 UTC2023-01N210134-001NP2022-07-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N210134-001NP2022-07-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N210134-001NP2022-07-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N210134-001NP2022-07-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N210134-001NP2022-07-24cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N210134-001NPP2028-03-17a50c72e98297…

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
Baqsimi
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLUCAGON3 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
76LA80IG2GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2180666Internal RxNorm lookup
2180671Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
32ba41fa-4158-40af-8cb2-03693c248994Available on FDA.report

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaqsimiGLUCAGONSportpharm LLC32ba41fa-4158-40af-8cb2-03693c2489942026-06-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 210134
application number: NDA210134
ndc (product): 85766-212
BaqsimiGLUCAGONAmphastar Pharmaceuticals, Inc.f1f5df9b-872f-44e5-a18f-f0b68e7e92542025-08-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 210134
application number: NDA210134

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-212-03857660212031 TUBE in 1 CARTON (85766-212-03) / 1 BOTTLE, UNIT-DOSE in 1 TUBE / 1 POWDER in 1 BOTTLE, UNIT-DOSE1 tube2026-06-19NoNoCurrent