Home NDC 47781-910 testosterone cypionate
Product NDC 47781-910
11-digit product format 477810910
Labeler code 47781
Product ID 47781-910_7b64b3e8-2013-fc50-c8db-926c9d1c4220
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name testosterone cypionate
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler Alvogen Inc.
Application ANDA207742
Marketing category ANDA
Marketing start 2022-11-02
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 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 A207742-001 TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207742-001 AO
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 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 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207742-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2017-06-16 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base testosterone cypionate
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 835840 Internal RxNorm lookup 2047882 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 47781-910-22 testosterone cypionate 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 4 47781-910-91 testosterone cypionate 10 in 1 CARTON INJECTION, SOLUTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47781-910 TESTOSTERONE CYPIONATE INJECTION, SOLUTION [ALVOGEN INC.] 3 Current NDC, Legacy NDC, 2 package rows 20241012_ed65346b-31bc-f872-516d-78d5ab70229e.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 47781-910-22 47781091022 10 mL in 1 VIAL, MULTI-DOSE 10 ml Historical 47781-910-91 47781091091 10 VIAL, MULTI-DOSE in 1 CARTON (47781-910-91) / 10 mL in 1 VIAL, MULTI-DOSE (47781-910-22) 2022-11-02 0000-00-00 No No Current