Home NDC 51991-192 Methscopolamine Bromide
Product NDC 51991-192
11-digit product format 519910192
Labeler code 51991
Product ID 51991-192_f9a49787-4f81-4993-996c-8b6453b1670c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methscopolamine bromide
Dosage form TABLET
Route ORAL
Labeler Breckenridge Pharmaceutical, Inc.
Application ANDA040642
Marketing category ANDA
Marketing start 2012-05-21
Substance METHSCOPOLAMINE BROMIDE
Active strength 5 mg/1
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040642-001 METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2011-12-06 A040642-002 METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2011-12-06
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 A040642-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2011-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040642-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2011-12-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040642-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2011-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040642-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2011-12-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040642-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2011-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040642-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2011-12-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040642-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2011-12-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040642-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2011-12-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040642-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2011-12-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040642-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2011-12-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040642-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2011-12-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040642-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2011-12-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040642-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2011-12-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040642-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2011-12-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040642-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2011-12-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040642-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2011-12-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040642-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2011-12-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040642-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2011-12-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040642-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2011-12-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040642-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2011-12-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040642-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2011-12-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040642-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2011-12-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040642-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2011-12-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040642-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2011-12-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040642-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2011-12-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040642-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2011-12-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040642-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2011-12-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040642-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2011-12-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040642-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2011-12-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040642-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2011-12-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040642-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2011-12-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040642-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2011-12-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040642-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2011-12-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040642-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2011-12-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040642-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL 2011-12-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040642-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL 2011-12-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040642-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2011-12-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040642-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2011-12-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040642-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2011-12-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040642-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2011-12-06 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Methscopolamine Bromide
Listing expiration 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 314088 Internal RxNorm lookup 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 51991-192-06 Methscopolamine Bromide 60 in 1 BOTTLE TABLET 60 6 51991-192-60 Methscopolamine Bromide 5 in 1 BOX TABLET 5 6 51991-192-60 Methscopolamine Bromide 12 in 1 BLISTER PACK TABLET 12 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded methscopolamine bromide ACTIVE INGREDIENT RTN51LK7WL METHSCOPOLAMINE BROMIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 1 methscopolamine ACTIVE MOIETY VDR09VTQ8U METHSCOPOLAMINE BROMIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U METHSCOPOLAMINE BROMIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 1 hydroxypropyl cellulose INACTIVE INGREDIENT RFW2ET671P METHSCOPOLAMINE BROMIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 METHSCOPOLAMINE BROMIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 1 starch, corn INACTIVE INGREDIENT O8232NY3SJ METHSCOPOLAMINE BROMIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51991-192 METHSCOPOLAMINE BROMIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 6 Current NDC, Legacy NDC, 3 package rows 20240327_157c1cce-bceb-4c74-8aa0-d2be9952d8f9.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 · 1 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 51991-192-06 51991019206 60 TABLET in 1 BOTTLE (51991-192-06) 60 tablet 2012-05-21 0000-00-00 No No Current 51991-192-60 51991019260 5 BLISTER PACK in 1 BOX (51991-192-60) / 12 TABLET in 1 BLISTER PACK 5 blister pack 2012-05-21 0000-00-00 No No Current