Home NDC 70518-4538 TESTOSTERONE CYPIONATE
Product NDC 70518-4538
11-digit product format 705184538
Labeler code 70518
Product ID 70518-4538_464f2ad8-ef6f-717f-e063-6294a90a9b07
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name testosterone cypionate
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler REMEDYREPACK INC.
Application ANDA210362
Marketing category ANDA
Marketing start 2025-12-17
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210362-001 TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2018-06-19 A210362-002 TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2018-06-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 84 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 A210362-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2018-06-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210362-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2018-06-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210362-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2018-06-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210362-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2018-06-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210362-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2018-06-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210362-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2018-06-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210362-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2018-06-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210362-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2018-06-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210362-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2018-06-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210362-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2018-06-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210362-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2018-06-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210362-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2018-06-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210362-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2018-06-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210362-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2018-06-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210362-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2018-06-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210362-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2018-06-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210362-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2018-06-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210362-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2018-06-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210362-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2018-06-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210362-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2018-06-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210362-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2018-06-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210362-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2018-06-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210362-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2018-06-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210362-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2018-06-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210362-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2018-06-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210362-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2018-06-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210362-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2018-06-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210362-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2018-06-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210362-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2018-06-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210362-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2018-06-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210362-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2018-06-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210362-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2018-06-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210362-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2018-06-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210362-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2018-06-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210362-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2018-06-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210362-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2018-06-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210362-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2018-06-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210362-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2018-06-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210362-001 TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO 2018-06-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210362-002 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2018-06-19 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 70518-4538-0 TESTOSTERONE CYPIONATE 1 mL in 1 VIAL, GLASS INJECTION 1 3
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4538-0 70518453800 1 mL in 1 VIAL, GLASS (70518-4538-0) 1 ml 2025-12-17 No No Current