Home NDC 0722-7183 Mecamylamine Hydrochloride
Product NDC 0722-7183
11-digit product format 007227183
Labeler code 0722
Product ID 0722-7183_9492a529-c29e-4833-9659-33b8a8694874
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mecamylamine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Nexgen Pharma, Inc.
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 2020-12-31
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 · 38 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0722-7183-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0722-7183-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0722-7183-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0722-7183-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0722-7183-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0722-7183-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0722-7183-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0722-7183-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0722-7183-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0722-7183-01 ad56d346431e…cc804d4bbf1e…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 0722-7183-01 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 0722-7183-01 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 0722-7183-01 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 0722-7183-01 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 0722-7183-01 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0722-7183-01 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0722-7183-01 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 0722-7183-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 0722-7183-01 8dfbde2a14a4…c9ff85d89658…
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 0722-7183-01 Mecamylamine Hydrochloride 100 in 1 BOTTLE TABLET 100 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Mecamylamine Hydrochloride ACTIVE INGREDIENT 4956DJR58O MECAMYLAMINE HYDROCHLORIDE TABLET [NEXGEN PHARMA, INC.] 1 Mecamylamine ACTIVE MOIETY 6EE945D3OK MECAMYLAMINE HYDROCHLORIDE TABLET [NEXGEN PHARMA, INC.] 1 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP MECAMYLAMINE HYDROCHLORIDE TABLET [NEXGEN PHARMA, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G MECAMYLAMINE HYDROCHLORIDE TABLET [NEXGEN PHARMA, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 MECAMYLAMINE HYDROCHLORIDE TABLET [NEXGEN PHARMA, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MECAMYLAMINE HYDROCHLORIDE TABLET [NEXGEN PHARMA, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MECAMYLAMINE HYDROCHLORIDE TABLET [NEXGEN PHARMA, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MECAMYLAMINE HYDROCHLORIDE TABLET [NEXGEN PHARMA, INC.] 1 Talc INACTIVE INGREDIENT 7SEV7J4R1U MECAMYLAMINE HYDROCHLORIDE TABLET [NEXGEN PHARMA, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R MECAMYLAMINE HYDROCHLORIDE TABLET [NEXGEN PHARMA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0722-7183 MECAMYLAMINE HYDROCHLORIDE TABLET [NEXGEN PHARMA, INC.] 2 Legacy NDC, 1 package rows 20190906_b87994ee-26a5-4d00-99e7-796bc17961f1.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 Status 0722-7183-01 00722718301 100 in 1 BOTTLE Historical