Home NDC 0591-3216 Testosterone
Product NDC 0591-3216
11-digit product format 005913216
Labeler code 0591
Product ID 0591-3216_38f554a5-ee64-4429-96c5-52b02c7763c1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Testosterone
Dosage form GEL
Route TOPICAL
Labeler Actavis Pharma, Inc.
Application ANDA076737
Marketing category ANDA
Marketing start 2015-12-04
Substance TESTOSTERONE
Active strength 10 mg/g
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 1 .
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 A076737-001 TESTOSTERONE TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2006-01-27 A076737-002 TESTOSTERONE TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 RS 2006-01-27 A076737-003 TESTOSTERONE TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 RS 2015-03-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 · 123 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 2026-02-19 14:30 UTC 2026-02 A076737-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2006-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076737-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 RS 2006-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076737-003 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 RS 2015-03-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076737-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2006-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076737-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 RS 2006-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076737-003 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 RS 2015-03-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076737-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2006-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076737-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 RS 2006-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076737-003 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 RS 2015-03-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076737-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2006-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076737-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 RS 2006-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076737-003 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 RS 2015-03-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076737-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2006-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076737-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 RS 2006-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076737-003 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 RS 2015-03-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076737-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2006-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076737-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 RS 2006-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076737-003 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 RS 2015-03-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076737-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2006-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076737-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 RS 2006-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076737-003 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 RS 2015-03-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076737-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2006-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076737-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 RS 2006-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076737-003 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 RS 2015-03-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076737-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2006-01-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076737-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 RS 2006-01-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076737-003 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 RS 2015-03-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076737-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2006-01-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076737-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 RS 2006-01-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076737-003 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 RS 2015-03-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076737-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2006-01-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076737-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 RS 2006-01-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076737-003 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 RS 2015-03-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076737-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2006-01-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076737-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 RS 2006-01-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076737-003 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 RS 2015-03-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076737-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2006-01-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076737-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 RS 2006-01-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076737-003 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 RS 2015-03-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076737-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2006-01-27 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Testosterone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TESTOSTERONE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3XMK78S47O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1596780 Internal RxNorm lookup 1597123 Internal RxNorm lookup 1597129 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 0591-3216-17 Testosterone 2.5 g in 1 PACKET GEL 2.5 21 0591-3216-30 Testosterone 30 in 1 CARTON GEL 30 21
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-3216 TESTOSTERONE GEL [ACTAVIS PHARMA, INC.] 18 Current NDC, Legacy NDC, 2 package rows 20230322_5834d34f-839d-412c-b74c-da1dad2cfa88.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 0591-3216-17 00591321617 2.5 g in 1 PACKET 2.5 g Historical 0591-3216-30 00591321630 30 PACKET in 1 CARTON (0591-3216-30) / 2.5 g in 1 PACKET (0591-3216-17) 30 packet 2015-12-04 0000-00-00 No No Current