Home NDC 71225-127 TESTOSTERONE
Product NDC 71225-127
11-digit product format 712250127
Labeler code 71225
Product ID 71225-127_fe8cb916-7dfb-44e5-b190-92484dd3385d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TESTOSTERONE CYPIONATE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler Slayback Pharma LLC
Application NDA216318
Marketing category NDA
Marketing start 2022-06-13
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71225-127-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71225-127-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71225-127-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71225-127-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71225-127-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 71225-127-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 71225-127-01 302b2466d912…e7b80fea0513…
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 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 2026-08-18 06:07:40 2026-07 N216318-001 AZMIRO 200MG/ML (200MG/ML) SOLUTION / INTRAMUSCULAR RLD, RS 2022-06-02 caaa826d4ba7…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 · 62 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N216318-001 11311554 2039-03-25 Drug product 2022-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216318-001 11642355 2039-03-25 Drug product 2023-05-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216318-001 12138271 2039-03-25 Drug product 2024-11-14 caaa826d4ba7…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…
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71225-127-01 71225012701 1 VIAL in 1 CARTON (71225-127-01) > 1 mL in 1 VIAL 1 vial 2022-06-13 0000-00-00 No No Current