Home NDC 0143-9750 TESTOSTERONE ENANTHATE
Product NDC 0143-9750
11-digit product format 001439750
Labeler code 0143
Product ID 0143-9750_8d67aa07-833f-4be7-8a7e-e49e19f49949
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TESTOSTERONE ENANTHATE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA091120
Marketing category ANDA
Marketing start 2012-09-18
Substance TESTOSTERONE ENANTHATE
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 2027-12-31
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 A091120-001 TESTOSTERONE ENANTHATE TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO RS 2012-09-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091120-001 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 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO RS 2012-09-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO RS 2012-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO RS 2012-09-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO RS 2012-09-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO RS 2012-09-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO RS 2012-09-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO RS 2012-09-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO RS 2012-09-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO RS 2012-09-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO RS 2012-09-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091120-001 TESTOSTERONE ENANTHATE 200MG/ML INJECTABLE / INJECTION AO 2012-09-18 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 ENANTHATE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TESTOSTERONE ENANTHATE 200 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7Z6522T8N9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 835809 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 0143-9750-01 TESTOSTERONE ENANTHATE 5 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 5 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9750 TESTOSTERONE ENANTHATE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 9 Current NDC, Legacy NDC, 1 package rows 20211116_e89d6458-428c-4256-97a3-f1fa851293c1.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.
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 0143-9750-01 00143975001 5 mL in 1 VIAL, MULTI-DOSE (0143-9750-01) 5 ml 2012-09-18 0000-00-00 No No Current