Home NDC 46708-654 Icatibant
Product NDC 46708-654
11-digit product format 467080654
Labeler code 46708
Product ID 46708-654_8c149392-d281-4311-880f-3be2b4752f40
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Icatibant
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler Alembic Pharmaceuticals Limited
Application ANDA213773
Marketing category ANDA
Marketing start 2024-06-14
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213773-001 ICATIBANT ACETATE ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP 2024-06-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213773-001 AP
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 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 A213773-001 ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP 2024-06-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213773-001 ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP 2024-06-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213773-001 ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP 2024-06-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213773-001 ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP 2024-06-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213773-001 ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP 2024-06-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213773-001 ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP 2024-06-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213773-001 ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP 2024-06-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213773-001 ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP 2024-06-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213773-001 ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP 2024-06-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213773-001 ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP 2024-06-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213773-001 ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP 2024-06-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213773-001 ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP 2024-06-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213773-001 ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP 2024-06-14 301d65b070ca…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213773-001 ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP 2024-06-14 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Icatibant
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ICATIBANT ACETATE 30 mg/3mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 325O8467XK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1148141 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 46708-654-03 Icatibant 3 mL in 1 SYRINGE, GLASS INJECTION 3 1 46708-654-03 Icatibant 1 in 1 CARTON INJECTION 1 1 46708-654-09 Icatibant 3 mL in 1 SYRINGE, GLASS INJECTION 3 1 46708-654-09 Icatibant 3 in 1 CARTON INJECTION 3 1
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 Marketing start Sample Exclude flag Status 46708-654-03 46708065403 1 SYRINGE, GLASS in 1 CARTON (46708-654-03) / 3 mL in 1 SYRINGE, GLASS 2024-06-14 No No Current 46708-654-09 46708065409 3 SYRINGE, GLASS in 1 CARTON (46708-654-09) / 3 mL in 1 SYRINGE, GLASS 2024-06-14 No No Current