Home NDC 79739-7183-1 Mecamylamine Hydrochloride
Product NDC 79739-7183
Requested package NDC 79739-7183-1
11-digit product format 797397183
Labeler code 79739
Product ID 79739-7183_1b79ef78-f4da-49a6-9f36-89b0da19d39b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mecamylamine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler LGM Pharma Solutions, LLC
Application ANDA204054
Marketing category ANDA
Marketing start 2013-03-19
Marketing end 0000-00-00
Substance MECAMYLAMINE HYDROCHLORIDE
Active strength 3 mg/1
Pharmacologic classes Autonomic Ganglionic Blocker [EPC],Decreased Autonomic Ganglionic Activity [PE]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 79739-7183 79739-7183-1 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 79739-7183 79739-7183-1 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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…
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 79739-7183-1 Mecamylamine Hydrochloride 100 in 1 BOTTLE TABLET 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79739-7183 MECAMYLAMINE HYDROCHLORIDE TABLET [LGM PHARMA SOLUTIONS, LLC] 2 Legacy NDC, 1 package rows 20240517_1b79ef78-f4da-49a6-9f36-89b0da19d39b.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 Marketing end Sample Exclude flag Status 79739-7183-1 79739718301 100 TABLET in 1 BOTTLE (79739-7183-1) 100 tablet 2013-03-19 0000-00-00 No No Current