Home NDC 75907-166-01 METYROSINE
Product NDC 75907-166
Requested package NDC 75907-166-01
11-digit product format 759070166
Labeler code 75907
Product ID 75907-166_cd87ec4e-09e2-40d7-831b-0b2e5205dafa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metyrosine
Dosage form CAPSULE
Route ORAL
Labeler Dr. Reddy's Laboratories Inc.
Application ANDA218620
Marketing category ANDA
Marketing start 2025-05-30
Substance METYROSINE
Active strength 250 mg/1
Pharmacologic classes Catecholamine Synthesis Inhibitor [EPC], Catecholamine Synthesis Inhibitors [MoA]
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 A218620-001 METYROSINE METYROSINE 250MG CAPSULE / ORAL AB 2025-04-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218620-001 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 A218620-001 METYROSINE 250MG CAPSULE / ORAL AB 2025-04-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218620-001 METYROSINE 250MG CAPSULE / ORAL AB 2025-04-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218620-001 METYROSINE 250MG CAPSULE / ORAL AB 2025-04-09 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218620-001 METYROSINE 250MG CAPSULE / ORAL AB 2025-04-09 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A218620-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218620-001 AB 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218620-001 AB 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218620-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base METYROSINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METYROSINE 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DOQ0J0TPF7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197980 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 75907-166-01 METYROSINE 100 in 1 BOTTLE CAPSULE 100 1 75907-166-30 METYROSINE 30 in 1 BOTTLE CAPSULE 30 1
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 Sample Exclude flag Status 75907-166-01 75907016601 100 CAPSULE in 1 BOTTLE (75907-166-01) 100 capsule 2025-05-30 No No Current