Home NDC 0409-6562-22 Testosterone Cypionate
Product NDC 0409-6562
Requested package NDC 0409-6562-22
11-digit product format 004096562
Labeler code 0409
Product ID 0409-6562_e56a4a35-f147-4f61-b47c-37aea1e6e558
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name testosterone cypionate
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler Hospira, Inc.
Application ANDA085635
Marketing category ANDA
Marketing start 2016-08-01
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
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0409-6562 0409-6562-22 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0409-6562 0409-6562-22 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A085635-001 DEPO-TESTOSTERONE TESTOSTERONE CYPIONATE 50MG/ML INJECTABLE / INJECTION Approved before 1982 A085635-002 DEPO-TESTOSTERONE TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 A085635-003 DEPO-TESTOSTERONE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982
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 4 · 132 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 2026-10-15 13:18:30 2026-09 A085635-001 DEPO-TESTOSTERONE 50MG/ML INJECTABLE / INJECTION Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 A085635-002 DEPO-TESTOSTERONE 100MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 A085635-003 DEPO-TESTOSTERONE 200MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 c2088c7a36db…2026-09-14 22:38:34 2026-08 A085635-001 DEPO-TESTOSTERONE 50MG/ML INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A085635-002 DEPO-TESTOSTERONE 100MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A085635-003 DEPO-TESTOSTERONE 200MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 84e616aacf4f…2026-08-18 06:07:40 2026-07 A085635-001 DEPO-TESTOSTERONE 50MG/ML INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A085635-002 DEPO-TESTOSTERONE 100MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A085635-003 DEPO-TESTOSTERONE 200MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A085635-001 DEPO-TESTOSTERONE 50MG/ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A085635-002 DEPO-TESTOSTERONE 100MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A085635-003 DEPO-TESTOSTERONE 200MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A085635-001 DEPO-TESTOSTERONE 50MG/ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A085635-002 DEPO-TESTOSTERONE 100MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A085635-003 DEPO-TESTOSTERONE 200MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A085635-001 DEPO-TESTOSTERONE 50MG/ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A085635-002 DEPO-TESTOSTERONE 100MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A085635-003 DEPO-TESTOSTERONE 200MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A085635-001 DEPO-TESTOSTERONE 50MG/ML INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A085635-002 DEPO-TESTOSTERONE 100MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A085635-003 DEPO-TESTOSTERONE 200MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A085635-001 DEPO-TESTOSTERONE 50MG/ML INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A085635-002 DEPO-TESTOSTERONE 100MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A085635-003 DEPO-TESTOSTERONE 200MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A085635-001 DEPO-TESTOSTERONE 50MG/ML INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A085635-002 DEPO-TESTOSTERONE 100MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A085635-003 DEPO-TESTOSTERONE 200MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A085635-001 DEPO-TESTOSTERONE 50MG/ML INJECTABLE / INJECTION Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A085635-002 DEPO-TESTOSTERONE 100MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A085635-003 DEPO-TESTOSTERONE 200MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A085635-001 DEPO-TESTOSTERONE 50MG/ML INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A085635-002 DEPO-TESTOSTERONE 100MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A085635-003 DEPO-TESTOSTERONE 200MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A085635-001 DEPO-TESTOSTERONE 50MG/ML INJECTABLE / INJECTION Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A085635-002 DEPO-TESTOSTERONE 100MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A085635-003 DEPO-TESTOSTERONE 200MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A085635-001 DEPO-TESTOSTERONE 50MG/ML INJECTABLE / INJECTION Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A085635-002 DEPO-TESTOSTERONE 100MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A085635-003 DEPO-TESTOSTERONE 200MG/ML INJECTABLE / INJECTION AO RLD, RS, Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A085635-001 DEPO-TESTOSTERONE 50MG/ML INJECTABLE / INJECTION Approved before 1982 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 835829 Internal RxNorm lookup 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 0409-6562-01 Testosterone Cypionate 1 mL in 1 VIAL INJECTION, SOLUTION 1 10 0409-6562-01 Testosterone Cypionate 1 in 1 CARTON INJECTION, SOLUTION 1 10 0409-6562-20 Testosterone Cypionate 10 mL in 1 VIAL INJECTION, SOLUTION 10 10 0409-6562-20 Testosterone Cypionate 1 in 1 CARTON INJECTION, SOLUTION 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-6562 TESTOSTERONE CYPIONATE INJECTION, SOLUTION [HOSPIRA, INC.] 8 Current NDC, Legacy NDC, 4 package rows 20200819_6909596e-4bf7-4e11-8029-b89740a30aec.zip 0409-6562 TESTOSTERONE CYPIONATE INJECTION, SOLUTION [HOSPIRA, INC.] 3 Current NDC, Legacy NDC 20200819_c5efc1ed-dd50-48fe-81b6-4d691a178630.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 0409-6562-22 00409656222 1 VIAL in 1 CARTON (0409-6562-22) > 10 mL in 1 VIAL 1 vial 2018-01-17 0000-00-00 No No Current