FDA.reportPublic FDA data

Glucagon

Product NDC
85766-043
11-digit product format
857660043
Labeler code
85766
Product ID
85766-043_4a23b6b9-6e87-37d2-e063-6294a90a431e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glucagon
Dosage form
KIT
Labeler
Sportpharm LLC
Application
ANDA218813
Marketing category
ANDA
Marketing start
2025-10-08
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 42.

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
A218813-001GLUCAGONGLUCAGON1MG/VIALINJECTABLE / INJECTIONAP2025-09-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A218813-001AP

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
A218813-001CGT2026-04-18

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A218813-001GLUCAGON1MG/VIALINJECTABLE / INJECTIONAP2025-09-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218813-001GLUCAGON1MG/VIALINJECTABLE / INJECTIONAP2025-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218813-001GLUCAGON1MG/VIALINJECTABLE / INJECTIONAP2025-09-1531067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218813-001GLUCAGON1MG/VIALINJECTABLE / INJECTIONAP2025-09-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A218813-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218813-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218813-001AP131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218813-001AP1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07A218813-001CGT2026-04-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218813-001CGT2026-04-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218813-001CGT2026-04-1831067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218813-001CGT2026-04-18a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Glucagon
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310497Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
34c3c58a-3d17-4a12-b592-971bdd41aecaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83f7a8cc-8fbf-4478-9a44-b6214b840d9aProduct name220250812
1e832aa0-608b-424f-9ced-615cef2ff5c5Product name120200220
6ee0758f-9a1a-41ee-90c4-3adce06b52b4Product name120191120
750a4794-c0e1-4ac9-9af5-006ecec3bb04Product name120150608

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-028-32Glucagon1 mL in 1 VIAL, GLASSINJECTION, POWDER, FOR SOLUTION1 mL1 mg in 1mL1
85766-043-01Glucagon1 in 1 CARTONKIT11

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
GlucagonGLUCAGONSportpharm LLC34c3c58a-3d17-4a12-b592-971bdd41aeca2026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218813
application number: ANDA218813
ndc (product): 85766-043
GlucagonGLUCAGONCipla USA Inc.6e80adb5-f45c-4f92-8dae-ee64217c676f2025-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218813
application number: ANDA218813

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310497glucagon (rDNA) 1 MG InjectionPSN34c3c58a-3d17-4a12-b592-971bdd41aeca1
310497glucagon (rDNA) 1 MG InjectionSCD34c3c58a-3d17-4a12-b592-971bdd41aeca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69097-028-32690970028321 mL in 1 VIAL, GLASS1 mlHistorical
85766-043-01857660043011 KIT in 1 CARTON (85766-043-01) * 1 mL in 1 VIAL, GLASS (69097-028-32) * 1 mL in 1 SYRINGE, GLASS (69097-029-31) 1 kit2026-02-06NoNoCurrent