Home NDC 43063-741 METHSCOPOLAMINE BROMIDE
Product NDC 43063-741
11-digit product format 430630741
Labeler code 43063
Product ID 43063-741_47a742ba-d521-2942-e063-6394a90a22fe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methscopolamine bromide
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA200602
Marketing category ANDA
Marketing start 2013-10-01
Substance METHSCOPOLAMINE BROMIDE
Active strength 5 mg/1
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A200602-001 METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2012-09-24 A200602-002 METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA RS 2012-09-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 A200602-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2012-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200602-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA RS 2012-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200602-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2012-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200602-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA RS 2012-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200602-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2012-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200602-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA RS 2012-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200602-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2012-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200602-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA RS 2012-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200602-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2012-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200602-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA RS 2012-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200602-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2012-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200602-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA RS 2012-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200602-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2012-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200602-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA RS 2012-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200602-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2012-09-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200602-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA RS 2012-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200602-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2012-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200602-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA RS 2012-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200602-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2012-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200602-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA RS 2012-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200602-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2012-09-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200602-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA RS 2012-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200602-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2012-09-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200602-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA RS 2012-09-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200602-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2012-09-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200602-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA RS 2012-09-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200602-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2012-09-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A200602-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA RS 2012-09-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200602-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2012-09-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200602-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA RS 2012-09-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200602-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2012-09-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A200602-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA RS 2012-09-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200602-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2012-09-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A200602-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA RS 2012-09-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200602-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2012-09-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A200602-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL RS 2012-09-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200602-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2012-09-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A200602-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA RS 2012-09-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200602-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2012-09-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A200602-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA RS 2012-09-24 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
Additional Listing Data#
Finished product Yes
Brand name base METHSCOPOLAMINE BROMIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHSCOPOLAMINE BROMIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RTN51LK7WL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 403914 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 43063-741-60 METHSCOPOLAMINE BROMIDE 60 in 1 BOTTLE, PLASTIC TABLET 60 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-741 METHSCOPOLAMINE BROMIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 9 Current NDC, Legacy NDC, 1 package rows 20241016_8a14ade6-d428-4144-9037-46955f68820f.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE Bryant Ranch Prepack 4ee28ed4-daff-462c-a38b-4fd8250ed9f4 2026-06-30 Warnings, Adverse reactions Exact identifier application applno (ANDA): 200602 application number: ANDA200602 METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE Bryant Ranch Prepack 6b8ed187-d378-4c95-80e0-0d3558a7aa95 2026-03-13 Warnings, Adverse reactions Exact identifier application applno (ANDA): 200602 application number: ANDA200602 METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE PD-Rx Pharmaceuticals, Inc. 26cd56db-4727-40d1-8f08-3ee899052c77 2026-01-05 Warnings, Adverse reactions Exact identifier application applno (ANDA): 200602 application number: ANDA200602 METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE PD-Rx Pharmaceuticals, Inc. 8a14ade6-d428-4144-9037-46955f68820f 2026-01-05 Warnings, Adverse reactions Exact identifier application applno (ANDA): 200602 application number: ANDA200602 ndc (product): 43063-741 METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE Unichem Pharmaceuticals (USA), Inc. 5c74bfb0-c80a-4a86-acd1-1e3a1b20255d 2025-12-10 Warnings, Adverse reactions Exact identifier application applno (ANDA): 200602 application number: ANDA200602
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 43063-741-60 43063074160 60 TABLET in 1 BOTTLE, PLASTIC (43063-741-60) 60 tablet 2017-02-01 0000-00-00 No No Current