Home NDC 16714-969 testosterone
Product NDC 16714-969
11-digit product format 167140969
Labeler code 16714
Product ID 16714-969_136b02e0-e440-45ea-9b1f-3ad58db0c710
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name testosterone
Dosage form GEL
Route TOPICAL
Labeler Northstar Rx LLC
Application ANDA205781
Marketing category ANDA
Marketing start 2019-11-06
Substance TESTOSTERONE
Active strength 40.5 mg/2.5g
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205781-001 TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 A205781-002 TESTOSTERONE TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL / TRANSDERMAL AB2 RS 2017-07-12
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 · 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 A205781-001 TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205781-002 TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL / TRANSDERMAL AB2 RS 2017-07-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205781-001 TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205781-002 TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL / TRANSDERMAL AB2 RS 2017-07-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205781-001 TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205781-002 TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL / TRANSDERMAL AB2 RS 2017-07-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205781-001 TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205781-002 TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL / TRANSDERMAL AB2 RS 2017-07-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205781-001 TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205781-002 TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL / TRANSDERMAL AB2 RS 2017-07-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205781-001 TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205781-002 TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL / TRANSDERMAL AB2 RS 2017-07-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205781-001 TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205781-002 TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL / TRANSDERMAL AB2 RS 2017-07-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205781-001 TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205781-002 TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL / TRANSDERMAL AB2 RS 2017-07-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205781-001 TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205781-002 TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL / TRANSDERMAL AB2 RS 2017-07-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205781-001 TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205781-002 TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL / TRANSDERMAL AB2 RS 2017-07-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205781-001 TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205781-002 TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL / TRANSDERMAL AB2 RS 2017-07-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205781-001 TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205781-002 TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL / TRANSDERMAL AB2 RS 2017-07-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205781-001 TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205781-002 TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL / TRANSDERMAL AB2 RS 2017-07-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205781-001 TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205781-002 TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL / TRANSDERMAL AB2 RS 2017-07-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205781-001 TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205781-002 TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL / TRANSDERMAL AB2 RS 2017-07-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205781-001 TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205781-002 TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL / TRANSDERMAL AB2 RS 2017-07-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205781-001 TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205781-002 TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL / TRANSDERMAL AB2 RS 2017-07-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205781-001 TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A205781-002 TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205781-001 TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205781-002 TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL / TRANSDERMAL AB2 RS 2017-07-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205781-001 TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A205781-002 TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL / TRANSDERMAL AB2 2017-07-12 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 40.5 mg/2.5g
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 1597120 Internal RxNorm lookup 1597126 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 16714-969-01 testosterone 2.5 g in 1 PACKET GEL 2.5 10 16714-969-02 testosterone 30 in 1 CARTON GEL 30 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-969 TESTOSTERONE GEL [NORTHSTAR RX LLC] 8 Current NDC, Legacy NDC, 2 package rows 20240315_2d55b825-8eab-4091-bdf2-9c52d111b8eb.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 16714-969-01 16714096901 2.5 g in 1 PACKET 2.5 g Historical 16714-969-02 16714096902 30 PACKET in 1 CARTON (16714-969-02) / 2.5 g in 1 PACKET (16714-969-01) 30 packet 2019-11-06 0000-00-00 No No Current