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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022150-001 | FIRAZYR | ICATIBANT ACETATE | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N022150-001 | 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 | 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 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | RLD, RS | 2011-08-25 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N022150-001 | FIRAZYR | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 2011-08-25 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N022150-001 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022150-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022150-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022150-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022150-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022150-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022150-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022150-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022150-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022150-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022150-001 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022150-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022150-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022150-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022150-001 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022150-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022150-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022150-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022150-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022150-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022150-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022150-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022150-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N022150-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022150-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N022150-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022150-001 | AP | 1 | b00525d2431f… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022150-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N022150-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N022150-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022150-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022150-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022150-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022150-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N022150-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N022150-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022150-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022150-001 | AP | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N022150-001 | AP | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022150-001 | AP | 1 | cb3db0bc1861… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N022150-001 | 5648333 | 2019-07-15 | U-1187 | Drug substance, Drug product | 2011-09-22 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | N022150-001 | 5648333 | 2019-07-15 | U-1187 | Drug substance, Drug product | 2011-09-22 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022150-001 | 5648333 | 2019-07-15 | U-1187 | Drug substance, Drug product | 2011-09-22 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022150-001 | 5648333 | 2019-07-15 | U-1187 | Drug substance, Drug product | 2011-09-22 | ea99ee380514… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Firazyr
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ICATIBANT ACETATE | 30 mg/3mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 325O8467XK | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ed6657ca-ab68-477a-9968-e12dc928b540 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 94785027-dc4b-8998-43d4-c818590b3995 | Product name | 6 | 20241008 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54092-702-01 | Firazyr | 3 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 3 | 19 | |
| 54092-702-01 | Firazyr | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 19 | |
| 54092-702-02 | Firazyr | 3 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 3 | 19 | |
| 54092-702-02 | Firazyr | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 19 | |
| 54092-702-03 | Firazyr | 3 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 3 | 19 | |
| 54092-702-03 | Firazyr | 3 in 1 CARTON | INJECTION, SOLUTION | 3 | 19 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54092-702-02 | ML - Milliliter | 54092-702 | 054deaeb-401e-445e-a503-c80f61cd377a | 1 | 2012-07-24 |
| 54092-702-03 | ML - Milliliter | 54092-702 | 9a9a11e1-82a6-41e2-99a9-2c5c9b177169 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| icatibant acetate | ACTIVE INGREDIENT | 325O8467XK | FIRAZYR (ICATIBANT ACETATE) INJECTION, SOLUTION [SHIRE US MANUFACTURING INC.] | 9 | |
| icatibant | ACTIVE MOIETY | 7PG89G35Q7 | FIRAZYR (ICATIBANT ACETATE) INJECTION, SOLUTION [SHIRE US MANUFACTURING INC.] | 9 | |
| acetic acid | INACTIVE INGREDIENT | Q40Q9N063P | FIRAZYR (ICATIBANT ACETATE) INJECTION, SOLUTION [SHIRE US MANUFACTURING INC.] | 9 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | FIRAZYR (ICATIBANT ACETATE) INJECTION, SOLUTION [SHIRE US MANUFACTURING INC.] | 9 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | FIRAZYR (ICATIBANT ACETATE) INJECTION, SOLUTION [SHIRE US MANUFACTURING INC.] | 9 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | FIRAZYR (ICATIBANT ACETATE) INJECTION, SOLUTION [SHIRE US MANUFACTURING INC.] | 9 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Firazyr | ICATIBANT ACETATE | Takeda Pharmaceuticals America, Inc. | ed6657ca-ab68-477a-9968-e12dc928b540 | 2025-07-07 | Warnings, Adverse reactions | 022150 NDA022150 54092-702 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1148145 | firazyr 30 MG in 3 ML Prefilled Syringe | PSN | ed6657ca-ab68-477a-9968-e12dc928b540 | 19 |
| 1148141 | icatibant 30 MG in 3 ML Prefilled Syringe | PSN | ed6657ca-ab68-477a-9968-e12dc928b540 | 19 |
| 1148145 | 3 ML icatibant 10 MG/ML Prefilled Syringe [Firazyr] | SBD | ed6657ca-ab68-477a-9968-e12dc928b540 | 19 |
| 1148141 | 3 ML icatibant 10 MG/ML Prefilled Syringe | SCD | ed6657ca-ab68-477a-9968-e12dc928b540 | 19 |
| 1148145 | 3 ML Firazyr 10 MG/ML (as icatibant acetate) Prefilled Syringe | SY | ed6657ca-ab68-477a-9968-e12dc928b540 | 19 |
| 1148145 | 3 ML Firazyr 10 MG/ML Prefilled Syringe | SY | ed6657ca-ab68-477a-9968-e12dc928b540 | 19 |
| 1148145 | Firazyr 30 MG per 3 ML Prefilled Syringe | SY | ed6657ca-ab68-477a-9968-e12dc928b540 | 19 |
| 1148141 | icatibant (as icatibant acetate) 30 MG per 3 ML Prefilled Syringe | SY | ed6657ca-ab68-477a-9968-e12dc928b540 | 19 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 54092-702-01 | 54092070201 | 1 SYRINGE, GLASS in 1 CARTON (54092-702-01) / 3 mL in 1 SYRINGE, GLASS | 2011-08-25 | 0000-00-00 | No | No | Current |
| 54092-702-02 | 54092070202 | 1 SYRINGE, GLASS in 1 CARTON (54092-702-02) / 3 mL in 1 SYRINGE, GLASS | 2011-08-25 | 0000-00-00 | No | No | Current |
| 54092-702-03 | 54092070203 | 3 SYRINGE, GLASS in 1 CARTON (54092-702-03) / 3 mL in 1 SYRINGE, GLASS | 2011-08-25 | 0000-00-00 | No | No | Current |