Home NDC 70954-255 Methyltestosterone
Product NDC 70954-255
11-digit product format 709540255
Labeler code 70954
Product ID 70954-255_987b3eb2-8e19-4ad6-bfdd-670b511d8dd6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methyltestosterone
Dosage form CAPSULE
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA215270
Marketing category ANDA
Marketing start 2022-02-18
Substance METHYLTESTOSTERONE
Active strength 10 mg/1
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215270-001 METHYLTESTOSTERONE METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215270-001 AB
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 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 4b0b4de00fa7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215270-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2022-02-18 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Methyltestosterone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLTESTOSTERONE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V9EFU16ZIF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197975 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 70954-255-10 Methyltestosterone 100 in 1 BOTTLE CAPSULE 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-255 METHYLTESTOSTERONE CAPSULE [NOVITIUM PHARMA LLC] 1 Current NDC, Legacy NDC, 1 package rows 20220223_c09c4cde-9f6c-4c4f-9d96-18beb5377564.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 70954-255-10 70954025510 100 CAPSULE in 1 BOTTLE (70954-255-10) 100 capsule 2022-02-18 0000-00-00 No No Current