Home NDC 0832-1120 Testosterone
Product NDC 0832-1120
11-digit product format 008321120
Labeler code 0832
Product ID 0832-1120_39853cd7-bfd1-848f-e063-6294a90a49e4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Testosterone
Dosage form GEL
Route TOPICAL
Labeler Upsher-Smith Laboratories, LLC
Application NDA204399
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2014-06-16
Substance TESTOSTERONE
Active strength 50 mg/5g
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 1 .
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 N204399-002 VOGELXO TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2014-06-04 N204399-003 VOGELXO TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL BX 2014-06-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204399-002 8785426 2034-02-11 U-1531 Drug product 2014-07-22 N204399-002 9295675 2034-02-11 U-1531 Drug product 2016-03-30 N204399-002 9662340 2034-02-11 U-1531 Drug product 2017-06-21 N204399-003 8785426 2034-02-11 U-1531 Drug product 2014-07-22 N204399-003 9295675 2034-02-11 U-1531 Drug product 2016-03-30 N204399-003 9662340 2034-02-11 U-1531 Drug product 2017-06-21
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 · 82 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 N204399-002 VOGELXO 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2014-06-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204399-003 VOGELXO 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL BX 2014-06-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204399-002 VOGELXO 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2014-06-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204399-003 VOGELXO 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL BX 2014-06-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204399-002 VOGELXO 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2014-06-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204399-003 VOGELXO 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL BX 2014-06-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204399-002 VOGELXO 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2014-06-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204399-003 VOGELXO 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL BX 2014-06-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204399-002 VOGELXO 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2014-06-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204399-003 VOGELXO 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL BX 2014-06-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204399-002 VOGELXO 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2014-06-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204399-003 VOGELXO 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL BX 2014-06-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204399-002 VOGELXO 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2014-06-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204399-003 VOGELXO 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL BX 2014-06-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204399-002 VOGELXO 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2014-06-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204399-003 VOGELXO 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL BX 2014-06-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204399-002 VOGELXO 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2014-06-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204399-003 VOGELXO 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL BX 2014-06-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204399-002 VOGELXO 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2014-06-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204399-003 VOGELXO 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL BX 2014-06-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204399-002 VOGELXO 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2014-06-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204399-003 VOGELXO 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL BX 2014-06-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204399-002 VOGELXO 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2014-06-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204399-003 VOGELXO 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL BX 2014-06-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204399-002 VOGELXO 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2014-06-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204399-003 VOGELXO 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL BX 2014-06-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204399-002 VOGELXO 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2014-06-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N204399-003 VOGELXO 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL BX 2014-06-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204399-002 VOGELXO 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2014-06-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204399-003 VOGELXO 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL BX 2014-06-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204399-002 VOGELXO 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2014-06-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N204399-003 VOGELXO 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL BX 2014-06-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204399-002 VOGELXO 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2014-06-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N204399-003 VOGELXO 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL BX 2014-06-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204399-002 VOGELXO 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2014-06-04 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N204399-003 VOGELXO 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL BX 2014-06-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204399-002 VOGELXO 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2014-06-04 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N204399-003 VOGELXO 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL BX 2014-06-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204399-002 VOGELXO 50MG/5GM PACKET GEL / TRANSDERMAL AB2 2014-06-04 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N204399-003 VOGELXO 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL BX 2014-06-04 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book patent history# Patent history page 1 of 7 · 246 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N204399-002 8785426 2034-02-11 U-1531 Drug product 2014-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204399-002 9295675 2034-02-11 U-1531 Drug product 2016-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204399-002 9662340 2034-02-11 U-1531 Drug product 2017-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204399-003 8785426 2034-02-11 U-1531 Drug product 2014-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204399-003 9295675 2034-02-11 U-1531 Drug product 2016-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204399-003 9662340 2034-02-11 U-1531 Drug product 2017-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204399-002 8785426 2034-02-11 U-1531 Drug product 2014-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204399-002 9295675 2034-02-11 U-1531 Drug product 2016-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204399-002 9662340 2034-02-11 U-1531 Drug product 2017-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204399-003 8785426 2034-02-11 U-1531 Drug product 2014-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204399-003 9295675 2034-02-11 U-1531 Drug product 2016-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204399-003 9662340 2034-02-11 U-1531 Drug product 2017-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204399-002 8785426 2034-02-11 U-1531 Drug product 2014-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204399-002 9295675 2034-02-11 U-1531 Drug product 2016-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204399-002 9662340 2034-02-11 U-1531 Drug product 2017-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204399-003 8785426 2034-02-11 U-1531 Drug product 2014-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204399-003 9295675 2034-02-11 U-1531 Drug product 2016-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204399-003 9662340 2034-02-11 U-1531 Drug product 2017-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204399-002 8785426 2034-02-11 U-1531 Drug product 2014-07-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204399-002 9295675 2034-02-11 U-1531 Drug product 2016-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204399-002 9662340 2034-02-11 U-1531 Drug product 2017-06-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204399-003 8785426 2034-02-11 U-1531 Drug product 2014-07-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204399-003 9295675 2034-02-11 U-1531 Drug product 2016-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204399-003 9662340 2034-02-11 U-1531 Drug product 2017-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204399-002 8785426 2034-02-11 U-1531 Drug product 2014-07-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204399-002 9295675 2034-02-11 U-1531 Drug product 2016-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204399-002 9662340 2034-02-11 U-1531 Drug product 2017-06-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204399-003 8785426 2034-02-11 U-1531 Drug product 2014-07-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204399-003 9295675 2034-02-11 U-1531 Drug product 2016-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204399-003 9662340 2034-02-11 U-1531 Drug product 2017-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204399-002 8785426 2034-02-11 U-1531 Drug product 2014-07-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204399-002 9295675 2034-02-11 U-1531 Drug product 2016-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204399-002 9662340 2034-02-11 U-1531 Drug product 2017-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204399-003 8785426 2034-02-11 U-1531 Drug product 2014-07-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204399-003 9295675 2034-02-11 U-1531 Drug product 2016-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204399-003 9662340 2034-02-11 U-1531 Drug product 2017-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204399-002 8785426 2034-02-11 U-1531 Drug product 2014-07-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204399-002 9295675 2034-02-11 U-1531 Drug product 2016-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204399-002 9662340 2034-02-11 U-1531 Drug product 2017-06-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204399-003 8785426 2034-02-11 U-1531 Drug product 2014-07-22 2680178bc6a6…
Additional Listing Data#
Finished product Yes
Brand name base Testosterone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TESTOSTERONE 50 mg/5g
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1596780 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# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Testosterone ACTIVE INGREDIENT 3XMK78S47O TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] 4 Testosterone ACTIVE MOIETY 3XMK78S47O TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] 4 alcohol INACTIVE INGREDIENT 3K9958V90M TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] 4 Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked) INACTIVE INGREDIENT 809Y72KV36 TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] 4 Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) INACTIVE INGREDIENT 4Q93RCW27E TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] 4 diisopropyl adipate INACTIVE INGREDIENT P7E6YFV72X TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] 4 glycerin INACTIVE INGREDIENT PDC6A3C0OX TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] 4 methyl laurate INACTIVE INGREDIENT 8IPS6BI6KW TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] 4 oleyl alcohol INACTIVE INGREDIENT 172F2WN8DV TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] 4 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] 4 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] 4 tromethamine INACTIVE INGREDIENT 023C2WHX2V TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] 4 water INACTIVE INGREDIENT 059QF0KO0R TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0832-1120 TESTOSTERONE GEL TESTOSTERONE GEL, METERED [UPSHER-SMITH LABORATORIES, LLC] 11 Current NDC, Legacy NDC, 4 package rows 20230517_a887020f-b41f-49fe-8379-f01147b2a796.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 · 2 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 0832-1120-05 00832112005 30 TUBE in 1 CARTON (0832-1120-05) / 5 g in 1 TUBE (0832-1120-65) 30 tube 2014-06-16 0000-00-00 No No Current 0832-1120-35 00832112035 30 PACKET in 1 CARTON (0832-1120-35) / 5 g in 1 PACKET (0832-1120-89) 30 packet 2014-06-16 0000-00-00 No No Current 0832-1120-65 00832112065 5 g in 1 TUBE 5 g Historical 0832-1120-89 00832112089 5 g in 1 PACKET 5 g Historical