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 43 .
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.
Product history page 1 of 2 · 43 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 2026-09-14 22:38:34 2026-08 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204054-001 MECAMYLAMINE HYDROCHLORIDE 2.5MG TABLET / ORAL RS 2013-03-19 f41ea6bd6efb…
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
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 · 2 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 83649-558-01 83649055801 100 TABLET in 1 BOTTLE (83649-558-01) 100 tablet 2025-02-20 No No Current