Home NDC 21922-019 Testosterone Gel, 1%
Product NDC 21922-019
11-digit product format 219220019
Labeler code 21922
Product ID 21922-019_afa51eef-714f-4b19-8c35-debee6cb00c4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Testosterone Gel, 1%
Dosage form GEL
Route TRANSDERMAL
Labeler Encube Ethicals, Inc.
Application ANDA212984
Marketing category ANDA
Marketing start 2021-01-10
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 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212984-001 TESTOSTERONE TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 A212984-002 TESTOSTERONE TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 A212984-003 TESTOSTERONE TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2024-07-11
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 2 · 57 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 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212984-003 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2024-07-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212984-003 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2024-07-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212984-003 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2024-07-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212984-003 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2024-07-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212984-003 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2024-07-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212984-003 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2024-07-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212984-003 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2024-07-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212984-003 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2024-07-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 57 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Testosterone Gel, 1%
Listing expiration 2026-12-31 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 21922-019-02 Testosterone Gel, 1% 5 g in 1 PACKET GEL 5 8 21922-019-02 Testosterone Gel, 1% 30 in 1 CARTON GEL 30 8 21922-019-47 Testosterone Gel, 1% 75 g in 1 CONTAINER GEL 75 8 21922-019-47 Testosterone Gel, 1% 2 in 1 CARTON GEL 2 8 21922-019-52 Testosterone Gel, 1% 25 g in 1 PACKET GEL 25 8 21922-019-52 Testosterone Gel, 1% 30 in 1 CARTON GEL 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21922-019 TESTOSTERONE GEL, 1% GEL [ENCUBE ETHICALS PRIVATE LIMITED] 7 Current NDC, Legacy NDC, 6 package rows 20250122_7d655d6d-01da-488c-bd4e-c7fbe0ace38c.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Testosterone Gel, 1% TESTOSTERONE GEL, 1% Bryant Ranch Prepack 353de205-d642-4f26-875b-b9ea4707a755 2026-04-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212984 application number: ANDA212984 Testosterone Gel, 1% TESTOSTERONE GEL, 1% Encube Ethicals, Inc. 7d655d6d-01da-488c-bd4e-c7fbe0ace38c 2025-10-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212984 application number: ANDA212984 ndc (product): 21922-019
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 21922-019-02 21922001902 30 PACKET in 1 CARTON (21922-019-02) / 5 g in 1 PACKET 30 packet 2021-01-10 0000-00-00 No No Current 21922-019-47 21922001947 2 CONTAINER in 1 CARTON (21922-019-47) / 75 g in 1 CONTAINER 2 container 2024-02-14 No No Current 21922-019-52 21922001952 30 PACKET in 1 CARTON (21922-019-52) / 25 g in 1 PACKET 30 packet 2024-08-12 No No Current