Home NDC 74676-0112 Tlando
Product NDC 74676-0112
11-digit product format 746760112
Labeler code 74676
Product ID 74676-0112_2bcfa6a9-635f-6bc9-ec72-839cca27541e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name testosterone undecanoate
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Verity Pharmaceuticals Inc.
Application NDA208088
Marketing category NDA
Marketing start 2022-04-15
Substance TESTOSTERONE UNDECANOATE
Active strength 112.5 mg/1
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208088-001 TLANDO TESTOSTERONE UNDECANOATE 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28
Orange Book patents# Current patent rows page 1 of 1 · 15 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208088-001 11304960 2029-01-08 U-1500 Drug product 2022-04-27 N208088-001 8778922 2029-01-08 U-1500 Drug product 2022-04-27 N208088-001 8865695 2029-01-08 U-1500 2022-04-27 N208088-001 10226473 2030-11-30 U-1500 2022-04-27 N208088-001 10716794 2030-11-30 U-1500 2022-04-27 N208088-001 11311555 2030-11-30 U-1500 2022-05-26 N208088-001 11364249 2030-11-30 U-1500 2022-07-19 N208088-001 11433083 2030-11-30 U-1500 2022-10-06 N208088-001 9943527 2030-11-30 U-1500 2022-04-27 N208088-001 9949985 2030-11-30 U-1500 2022-04-27 N208088-001 11559530 2037-11-28 U-1500 2023-02-14 N208088-001 12310978 2039-02-21 U-4194 2025-06-11 N208088-001 12011503 2040-10-16 U-3964 Drug product 2024-07-17 N208088-001 12011503 2040-10-16 U-3965 Drug product 2024-07-17 N208088-001 11464735 2041-04-28 U-1500 Drug product 2022-11-10
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.
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 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 5d02ea3f76ae…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N208088-001 TLANDO 112.5MG CAPSULE / ORAL RLD, RS 2022-03-28 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 9 · 360 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 N208088-001 11304960 2029-01-08 U-1500 Drug product 2022-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 8778922 2029-01-08 U-1500 Drug product 2022-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 8865695 2029-01-08 U-1500 2022-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 10226473 2030-11-30 U-1500 2022-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 10716794 2030-11-30 U-1500 2022-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 11311555 2030-11-30 U-1500 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 11364249 2030-11-30 U-1500 2022-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 11433083 2030-11-30 U-1500 2022-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 9943527 2030-11-30 U-1500 2022-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 9949985 2030-11-30 U-1500 2022-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 11559530 2037-11-28 U-1500 2023-02-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 12310978 2039-02-21 U-4194 2025-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 12011503 2040-10-16 U-3964 Drug product 2024-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 12011503 2040-10-16 U-3965 Drug product 2024-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208088-001 11464735 2041-04-28 U-1500 Drug product 2022-11-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 11304960 2029-01-08 U-1500 Drug product 2022-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 8778922 2029-01-08 U-1500 Drug product 2022-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 8865695 2029-01-08 U-1500 2022-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 10226473 2030-11-30 U-1500 2022-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 10716794 2030-11-30 U-1500 2022-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 11311555 2030-11-30 U-1500 2022-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 11364249 2030-11-30 U-1500 2022-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 11433083 2030-11-30 U-1500 2022-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 9943527 2030-11-30 U-1500 2022-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 9949985 2030-11-30 U-1500 2022-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 11559530 2037-11-28 U-1500 2023-02-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 12310978 2039-02-21 U-4194 2025-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 12011503 2040-10-16 U-3964 Drug product 2024-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 12011503 2040-10-16 U-3965 Drug product 2024-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208088-001 11464735 2041-04-28 U-1500 Drug product 2022-11-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208088-001 11304960 2029-01-08 U-1500 Drug product 2022-04-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208088-001 8778922 2029-01-08 U-1500 Drug product 2022-04-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208088-001 8865695 2029-01-08 U-1500 2022-04-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208088-001 10226473 2030-11-30 U-1500 2022-04-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208088-001 10716794 2030-11-30 U-1500 2022-04-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208088-001 11311555 2030-11-30 U-1500 2022-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208088-001 11364249 2030-11-30 U-1500 2022-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208088-001 11433083 2030-11-30 U-1500 2022-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208088-001 9943527 2030-11-30 U-1500 2022-04-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208088-001 9949985 2030-11-30 U-1500 2022-04-27 6a471c1ec25d…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Tlando
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TESTOSTERONE UNDECANOATE 112.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H16A5VCT9C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2599054 Internal RxNorm lookup 2599060 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 74676-0112-2 Tlando 120 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 120 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 74676-0112 TLANDOTEE-LAN-DOH (TESTOSTERONE UNDECANOATE) CAPSULE, LIQUID FILLED [VERITY PHARMACEUTICALS INC.] 3 Current NDC, 1 package rows 20240224_4b0b92e9-6d3c-a0e5-e1c7-342999f72580.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tlando TESTOSTERONE UNDECANOATE Verity Pharmaceuticals Inc. 4b0b92e9-6d3c-a0e5-e1c7-342999f72580 2026-02-25 Warnings, Adverse reactions Exact identifier application applno (NDA): 208088 application number: NDA208088 ndc (product): 74676-0112
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 74676-0112-2 74676011202 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (74676-0112-2) 2022-04-15 No No Current