Home NDC 0115-1408-08 MethylTESTOSTERone
Product NDC 0115-1408
Requested package NDC 0115-1408-08
11-digit product format 001151408
Labeler code 0115
Product ID 0115-1408_12d97eee-36cf-470e-819a-02ec2218fb94
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METHYLTESTOSTERONE
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA204851
Marketing category ANDA
Marketing start 2015-09-21
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 13 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A204851-001 METHYLTESTOSTERONE METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204851-001 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.
Product history page 1 of 2 · 41 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 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2015-09-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL RS 2015-09-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL RS 2015-09-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL RS 2015-09-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL RS 2015-09-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2015-09-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2015-09-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2015-09-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2015-09-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB 2015-09-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204851-001 METHYLTESTOSTERONE 10MG CAPSULE / ORAL AB RS 2015-09-21 cb3db0bc1861…
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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0115-1408-01 2025-06-03 Methyltestosterone Capsules, USP, CIII (10 mg) Rx only 0115-1408-03 2025-06-03 Methyltestosterone Capsules, USP, CIII (10 mg) Rx only 0115-1408-08 2025-06-03 Methyltestosterone Capsules, USP, CIII (10 mg) Rx only 0115-1408-01 2024-01-30 Methyltestosterone Capsules, USP, CIII (10 mg) Rx only 0115-1408-03 2024-01-30 Methyltestosterone Capsules, USP, CIII (10 mg) Rx only 0115-1408-08 2024-01-30 Methyltestosterone Capsules, USP, CIII (10 mg) Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0115-1408-01 MethylTESTOSTERone 100 in 1 BOTTLE CAPSULE 100 21 0115-1408-03 MethylTESTOSTERone 1000 in 1 BOTTLE CAPSULE 1000 21 0115-1408-08 MethylTESTOSTERone 30 in 1 BOTTLE CAPSULE 30 21
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0115-1408 METHYLTESTOSTERONE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 19 Current NDC, Legacy NDC, 3 package rows 20201230_9bed4886-fcd0-4056-be8d-5bb4d15081ce.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 0115-1408-08 00115140808 30 CAPSULE in 1 BOTTLE (0115-1408-08) 30 capsule 2015-09-21 0000-00-00 No No Current