Home NDC 0115-7037 METHITEST
Product NDC 0115-7037
11-digit product format 001157037
Labeler code 0115
Product ID 0115-7037_d5da1ec5-4a9e-4714-9240-039f802b2c1e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METHYLTESTOSTERONE
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA080767
Marketing category ANDA
Marketing start 1974-10-17
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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0115-7037-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0115-7037-01 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 0115-7037-01 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 0115-7037-01 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 0115-7037-01 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A080767-002 METHYLTESTOSTERONE METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A080767-002 BP
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 · 42 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 2026-08-18 06:07:40 2026-07 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A080767-002 METHYLTESTOSTERONE 10MG TABLET / ORAL BP Approved before 1982 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base METHITEST
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197976 Internal RxNorm lookup 541524 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0115-7037-01 METHITEST 100 in 1 BOTTLE TABLET 100 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHYLTESTOSTERONE ACTIVE INGREDIENT V9EFU16ZIF METHITEST (METHYLTESTOSTERONE) TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 METHYLTESTOSTERONE ACTIVE MOIETY V9EFU16ZIF METHITEST (METHYLTESTOSTERONE) TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 ACACIA INACTIVE INGREDIENT 5C5403N26O METHITEST (METHYLTESTOSTERONE) TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 GUAR GUM INACTIVE INGREDIENT E89I1637KE METHITEST (METHYLTESTOSTERONE) TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X METHITEST (METHYLTESTOSTERONE) TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METHITEST (METHYLTESTOSTERONE) TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M METHITEST (METHYLTESTOSTERONE) TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J METHITEST (METHYLTESTOSTERONE) TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METHITEST (METHYLTESTOSTERONE) TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 SUCROSE INACTIVE INGREDIENT C151H8M554 METHITEST (METHYLTESTOSTERONE) TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0115-7037 METHITEST (METHYLTESTOSTERONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 15 Current NDC, Legacy NDC, 1 package rows 20241022_77bb4ef4-c10e-4acc-8225-651d003f4561.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 METHITEST METHYLTESTOSTERONE Amneal Pharmaceuticals of New York LLC 77bb4ef4-c10e-4acc-8225-651d003f4561 2025-05-31 Warnings, Adverse reactions Exact identifier application applno (ANDA): 080767 application number: ANDA080767 ndc (product): 0115-7037
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 0115-7037-01 00115703701 100 TABLET in 1 BOTTLE (0115-7037-01) 100 tablet 1974-10-17 0000-00-00 No No Current