Home NDC 83649-558 Vecamyl
Product NDC 83649-558
11-digit product format 836490558
Labeler code 83649
Product ID 83649-558_f973c92e-e212-4f86-b8b4-e6bb45c7cbbd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mecamylamine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler TILDE Sciences LLC
Application ANDA204054
Marketing category ANDA
Marketing start 2013-03-19
Substance MECAMYLAMINE HYDROCHLORIDE
Active strength 2.5 mg/1
Pharmacologic classes Autonomic Ganglionic Blocker [EPC], Decreased Autonomic Ganglionic Activity [PE]
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 A204054-001 MECAMYLAMINE HYDROCHLORIDE MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19
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 2026-08-01 22:54:32 2026-06 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Vecamyl
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MECAMYLAMINE HYDROCHLORIDE 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4956DJR58O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1298874 Internal RxNorm lookup 1373008 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 83649-558-01 Vecamyl 100 in 1 BOTTLE TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83649-558 VECAMYL (MECAMYLAMINE HYDROCHLORIDE) TABLET [TILDE SCIENCES LLC] 1 Current NDC, 1 package rows 20250226_0b149023-f7a8-442d-ac69-295df8e66ed3.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83649-558-01 83649055801 100 TABLET in 1 BOTTLE (83649-558-01) 100 tablet 2025-02-20 No No Current