Firazyr

Product NDC
54092-702
11-digit product format
540920702
Labeler code
54092
Product ID
54092-702_19b83a10-9f38-4d0d-ae46-0f5b28168873
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
icatibant acetate
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA022150
Marketing category
NDA
Marketing start
2011-08-25
Substance
ICATIBANT ACETATE
Active strength
30 mg/3mL
Pharmacologic classes
Bradykinin B2 Receptor Antagonist [EPC], Bradykinin B2 Receptor Antagonists [MoA]
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022150-001FIRAZYRICATIBANT ACETATEEQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N022150-001AP

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
2026-08-18 06:07:402026-07N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-2587673890dc5c…
2021-03-12 10:30 UTC2021-03N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-253f01610625f2…
2019-09-15 20:21 UTC2019-09N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-25b00525d2431f…
2019-07-19 19:46 UTC2019-07N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2011-08-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-253f0d92c62455…
2023-05-13 08:27 UTC2023-05N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-25053a50430f4f…
2023-01-26 05:58 UTC2023-01N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022150-001FIRAZYREQ 30MG BASE/3ML (EQ 10MG BASE/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS2011-08-25e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N022150-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022150-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022150-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022150-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022150-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022150-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022150-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022150-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022150-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022150-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022150-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022150-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022150-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022150-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022150-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022150-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022150-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022150-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022150-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022150-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022150-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022150-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N022150-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022150-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022150-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022150-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N022150-001AP1b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022150-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022150-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022150-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022150-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022150-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022150-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022150-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N022150-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N022150-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022150-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022150-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022150-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022150-001AP1cb3db0bc1861…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N022150-00156483332019-07-15U-1187Drug substance, Drug product2011-09-2274a2ff9319b5…
2019-12-14 00:12 UTC2019-12N022150-00156483332019-07-15U-1187Drug substance, Drug product2011-09-223f01610625f2…
2019-09-15 20:21 UTC2019-09N022150-00156483332019-07-15U-1187Drug substance, Drug product2011-09-22b00525d2431f…
2019-07-19 19:46 UTC2019-07N022150-00156483332019-07-15U-1187Drug substance, Drug product2011-09-22ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
Firazyr
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ICATIBANT ACETATE30 mg/3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
325O8467XKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1148141Internal RxNorm lookup
1148145Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ed6657ca-ab68-477a-9968-e12dc928b540Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94785027-dc4b-8998-43d4-c818590b3995Product name620241008
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54092-702-01Firazyr3 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION319
54092-702-01Firazyr1 in 1 CARTONINJECTION, SOLUTION119
54092-702-02Firazyr3 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION319
54092-702-02Firazyr1 in 1 CARTONINJECTION, SOLUTION119
54092-702-03Firazyr3 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION319
54092-702-03Firazyr3 in 1 CARTONINJECTION, SOLUTION319

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54092-702-02ML - Milliliter54092-702054deaeb-401e-445e-a503-c80f61cd377a12012-07-24
54092-702-03ML - Milliliter54092-7029a9a11e1-82a6-41e2-99a9-2c5c9b17716912012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54092-702FIRAZYR (ICATIBANT ACETATE) INJECTION, SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.]18Current NDC, Legacy NDC, 6 package rows20240131_ed6657ca-ab68-477a-9968-e12dc928b540.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FirazyrICATIBANT ACETATETakeda Pharmaceuticals America, Inc.ed6657ca-ab68-477a-9968-e12dc928b5402025-07-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 022150
application number: NDA022150
ndc (product): 54092-702

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148145firazyr 30 MG in 3 ML Prefilled SyringePSNed6657ca-ab68-477a-9968-e12dc928b54019
1148141icatibant 30 MG in 3 ML Prefilled SyringePSNed6657ca-ab68-477a-9968-e12dc928b54019
11481453 ML icatibant 10 MG/ML Prefilled Syringe [Firazyr]SBDed6657ca-ab68-477a-9968-e12dc928b54019
11481413 ML icatibant 10 MG/ML Prefilled SyringeSCDed6657ca-ab68-477a-9968-e12dc928b54019
11481453 ML Firazyr 10 MG/ML (as icatibant acetate) Prefilled SyringeSYed6657ca-ab68-477a-9968-e12dc928b54019
11481453 ML Firazyr 10 MG/ML Prefilled SyringeSYed6657ca-ab68-477a-9968-e12dc928b54019
1148145Firazyr 30 MG per 3 ML Prefilled SyringeSYed6657ca-ab68-477a-9968-e12dc928b54019
1148141icatibant (as icatibant acetate) 30 MG per 3 ML Prefilled SyringeSYed6657ca-ab68-477a-9968-e12dc928b54019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54092-702-01540920702011 SYRINGE, GLASS in 1 CARTON (54092-702-01) / 3 mL in 1 SYRINGE, GLASS2011-08-250000-00-00NoNoCurrent
54092-702-02540920702021 SYRINGE, GLASS in 1 CARTON (54092-702-02) / 3 mL in 1 SYRINGE, GLASS2011-08-250000-00-00NoNoCurrent
54092-702-03540920702033 SYRINGE, GLASS in 1 CARTON (54092-702-03) / 3 mL in 1 SYRINGE, GLASS2011-08-250000-00-00NoNoCurrent