Home NDC 24338-055 AZMIRO
Product NDC 24338-055
11-digit product format 243380055
Labeler code 24338
Product ID 24338-055_5cf15fb2-1ba1-4295-9ddf-e98434ccd1c2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TESTOSTERONE CYPIONATE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler Azurity Pharmaceuticals, Inc.
Application NDA216318
Marketing category NDA
Marketing start 2024-10-04
Substance TESTOSTERONE CYPIONATE
Active strength 200 mg/mL
Pharmacologic classes Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule CIII
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 1 .
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 N216318-001 AZMIRO TESTOSTERONE CYPIONATE 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD, RS 2022-06-02
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216318-001 11311554 2039-03-25 Drug product 2022-06-03 N216318-001 11642355 2039-03-25 Drug product 2023-05-12 N216318-001 12138271 2039-03-25 Drug product 2024-11-14
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 2026-02-19 14:30 UTC 2026-02 N216318-001 AZMIRO 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD, RS 2022-06-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216318-001 AZMIRO 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD, RS 2022-06-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216318-001 AZMIRO 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD, RS 2022-06-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216318-001 AZMIRO 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD, RS 2022-06-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216318-001 AZMIRO 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD, RS 2022-06-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216318-001 AZMIRO 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD, RS 2022-06-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216318-001 AZMIRO 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD, RS 2022-06-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216318-001 TESTOSTERONE CYPIONATE 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD 2022-06-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216318-001 AZMIRO 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD, RS 2022-06-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216318-001 TESTOSTERONE CYPIONATE 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD, RS 2022-06-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216318-001 TESTOSTERONE CYPIONATE 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD 2022-06-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216318-001 TESTOSTERONE CYPIONATE 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD 2022-06-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216318-001 TESTOSTERONE CYPIONATE 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD 2022-06-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216318-001 TESTOSTERONE CYPIONATE 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD 2022-06-02 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216318-001 TESTOSTERONE CYPIONATE 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD 2022-06-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216318-001 TESTOSTERONE CYPIONATE 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD 2022-06-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216318-001 TESTOSTERONE CYPIONATE 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD 2022-06-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216318-001 TESTOSTERONE CYPIONATE 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD 2022-06-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216318-001 TESTOSTERONE CYPIONATE 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD 2022-06-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N216318-001 TESTOSTERONE CYPIONATE 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD 2022-06-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N216318-001 TESTOSTERONE CYPIONATE 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD 2022-06-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N216318-001 TESTOSTERONE CYPIONATE 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD 2022-06-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N216318-001 TESTOSTERONE CYPIONATE 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD 2022-06-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N216318-001 TESTOSTERONE CYPIONATE 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD 2022-06-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N216318-001 TESTOSTERONE CYPIONATE 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD 2022-06-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N216318-001 TESTOSTERONE CYPIONATE 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD, RS 2022-06-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N216318-001 TESTOSTERONE CYPIONATE 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD, RS 2022-06-02 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216318-001 AZMIRO 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD, RS 2022-06-02 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 59 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N216318-001 11311554 2039-03-25 Drug product 2022-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216318-001 11642355 2039-03-25 Drug product 2023-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216318-001 12138271 2039-03-25 Drug product 2024-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216318-001 11311554 2039-03-25 Drug product 2022-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216318-001 11642355 2039-03-25 Drug product 2023-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216318-001 12138271 2039-03-25 Drug product 2024-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216318-001 11311554 2039-03-25 Drug product 2022-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216318-001 11642355 2039-03-25 Drug product 2023-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216318-001 12138271 2039-03-25 Drug product 2024-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216318-001 11311554 2039-03-25 Drug product 2022-06-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216318-001 11642355 2039-03-25 Drug product 2023-05-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216318-001 12138271 2039-03-25 Drug product 2024-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216318-001 11311554 2039-03-25 Drug product 2022-06-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216318-001 11642355 2039-03-25 Drug product 2023-05-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216318-001 12138271 2039-03-25 Drug product 2024-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216318-001 11311554 2039-03-25 Drug product 2022-06-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216318-001 11642355 2039-03-25 Drug product 2023-05-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216318-001 12138271 2039-03-25 Drug product 2024-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216318-001 11311554 2039-03-25 Drug product 2022-06-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216318-001 11642355 2039-03-25 Drug product 2023-05-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216318-001 12138271 2039-03-25 Drug product 2024-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216318-001 11311554 2039-03-25 Drug product 2022-06-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216318-001 11642355 2039-03-25 Drug product 2023-05-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216318-001 11311554 2039-03-25 Drug product 2022-06-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216318-001 11642355 2039-03-25 Drug product 2023-05-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216318-001 11311554 2039-03-25 Drug product 2022-06-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216318-001 11642355 2039-03-25 Drug product 2023-05-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216318-001 11311554 2039-03-25 Drug product 2022-06-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216318-001 11642355 2039-03-25 Drug product 2023-05-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216318-001 11311554 2039-03-25 Drug product 2022-06-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216318-001 11642355 2039-03-25 Drug product 2023-05-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216318-001 11311554 2039-03-25 Drug product 2022-06-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216318-001 11642355 2039-03-25 Drug product 2023-05-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216318-001 11311554 2039-03-25 Drug product 2022-06-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N216318-001 11642355 2039-03-25 Drug product 2023-05-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N216318-001 11311554 2039-03-25 Drug product 2022-06-03 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216318-001 11311554 2039-03-25 Drug product 2022-06-03 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216318-001 11642355 2039-03-25 Drug product 2023-05-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216318-001 11311554 2039-03-25 Drug product 2022-06-03 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N216318-001 11642355 2039-03-25 Drug product 2023-05-12 1c564ffb4f44…
Additional Listing Data#
Finished product Yes
Brand name base AZMIRO
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TESTOSTERONE CYPIONATE 200 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M0XW1UBI14 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2047882 Internal RxNorm lookup 2694309 Internal RxNorm lookup 2694316 Internal RxNorm lookup 2694320 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 24338-055-01 AZMIRO 1 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 1 3 24338-055-01 AZMIRO 1 in 1 CARTON INJECTION, SOLUTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24338-055 AZMIRO (TESTOSTERONE CYPIONATE) INJECTION, SOLUTION [AZURITY PHARMACEUTICALS, INC.] 2 Current NDC, 2 package rows 20250105_235b5625-570d-3fba-e063-6394a90aa2d1.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AZMIRO TESTOSTERONE CYPIONATE Azurity Pharmaceuticals, Inc. 235b5625-570d-3fba-e063-6394a90aa2d1 2025-07-25 Warnings, Adverse reactions Exact identifier application applno (NDA): 216318 application number: NDA216318 ndc (product): 24338-055
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 24338-055-01 24338005501 1 SYRINGE, GLASS in 1 CARTON (24338-055-01) / 1 mL in 1 SYRINGE, GLASS 2024-10-04 No No Current