FDA.reportPublic FDA data

Application 201849

Type
NDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLUCAGONGLUCAGON HYDROCHLORIDEPOWDER;INTRAMUSCULAR, INTRAVENOUSEQ 1MG BASE/VIALYesYes
002GLUCAGONGLUCAGON HYDROCHLORIDEPOWDER;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSEQ 1MG BASE/VIALYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N201849-001GLUCAGONGLUCAGON HYDROCHLORIDEEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUSRLD, RS2015-05-08
N201849-002GLUCAGONGLUCAGON HYDROCHLORIDEEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSRLD, RS2019-09-19

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 2 of 2 · 62 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N201849-001GLUCAGONEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUSRLD, RS2015-05-0887673890dc5c…
2021-03-12 10:30 UTC2021-03N201849-001GLUCAGONEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUSRLD, RS2015-05-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N201849-001GLUCAGONEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUSRLD, RS2015-05-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N201849-001GLUCAGONEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUSRLD, RS2015-05-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N201849-001GLUCAGONEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUSRLD, RS2015-05-083f01610625f2…
2019-09-15 20:21 UTC2019-09N201849-001GLUCAGONEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUSRLD, RS2015-05-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N201849-001GLUCAGONEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUSRLD, RS2015-05-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N201849-001GLUCAGONEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUSRLD, RS2015-05-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N201849-001GLUCAGONEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUSRLD, RS2015-05-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12N201849-001GLUCAGONEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUSRLD, RS2015-05-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N201849-001GLUCAGONEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUSRLD, RS2015-05-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N201849-001GLUCAGONEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUSRLD, RS2015-05-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N201849-001GLUCAGONEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUSRLD, RS2015-05-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N201849-001GLUCAGONEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUSRLD, RS2015-05-083f0d92c62455…
2023-05-13 08:27 UTC2023-05N201849-001GLUCAGONEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUSRLD, RS2015-05-08053a50430f4f…
2023-01-26 05:58 UTC2023-01N201849-001GLUCAGONEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUSRLD, RS2015-05-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N201849-001GLUCAGONEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUSRLD, RS2015-05-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N201849-001GLUCAGONEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUSRLD, RS2015-05-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N201849-001GLUCAGONEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUSRLD, RS2015-05-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N201849-001GLUCAGONEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUSRLD, RS2015-05-08cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N201849-001GLUCAGONEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUSRLD, RS2015-05-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N201849-002GLUCAGONEQ 1MG BASE/VIALPOWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSRLD, RS2019-09-19a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlucagonGLUCAGONFresenius Kabi USA, LLCc5c431b4-5618-4ff4-954e-4c0fbfed67b62025-03-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 201849
application number: NDA201849
ndc (product): 63323-582
GLUCAGONGLUCAGONHF Acquisition Co LLC, DBA HealthFirsta0845f53-edad-e28f-e053-2995a90a31cf2024-02-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 201849
application number: NDA201849
ndc (product): 51662-1498
GlucagonGLUCAGONFresenius Kabi USA, LLC8c8acad6-44cc-43aa-966b-027e053be8f52022-04-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 201849
application number: NDA201849
ndc (product): 63323-594
ndc (product): 63323-596
GlucagonGLUCAGONFresenius Kabi USA, LLCe4be1c0e-0fe6-45a0-9229-5cde98434b842020-09-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 201849
application number: NDA201849
ndc (product): 63323-593
ndc (product): 63323-596

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51662-1498GLUCAGONGLUCAGONHF Acquisition Co LLC, DBA HealthFirstNDACurrent
63323-582GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-582GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-593GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-593GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-593GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-593GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-594GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-594GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-594GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-594GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-594GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-596GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-596GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-596GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-596GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-596GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-596GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-596GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-596GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-596GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83367SUPPL 2025-09-17
83364SUPPL 2025-09-17
71574SUPPL2022-07-15
71557SUPPL2022-07-15
68263SUPPL2021-08-02
68257SUPPL2021-08-02
59975SUPPL2019-09-11
59966SUPPL2019-09-11
22863ORIG2016-05-25
19036SUPPL2015-12-02
9934SUPPL2015-12-02
32142ORIG2015-05-13