Home NDC 72319-030 METHSCOPOLAMINE BROMIDE
Product NDC 72319-030
11-digit product format 723190030
Labeler code 72319
Product ID 72319-030_2ee941f2-7d8c-dd6e-e063-6394a90a0db9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methscopolamine bromide
Dosage form TABLET
Route ORAL
Labeler i3 Pharmaceuticals, LLC
Application ANDA216786
Marketing category ANDA
Marketing start 2024-12-18
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 A216786-001 METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2024-02-01 A216786-002 METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2024-02-01
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.
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 A216786-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2024-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216786-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2024-02-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216786-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2024-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216786-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2024-02-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216786-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2024-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216786-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2024-02-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216786-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2024-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216786-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2024-02-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216786-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2024-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216786-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2024-02-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216786-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2024-02-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216786-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2024-02-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216786-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2024-02-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216786-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2024-02-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216786-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2024-02-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216786-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2024-02-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216786-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2024-02-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216786-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2024-02-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216786-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2024-02-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216786-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2024-02-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216786-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2024-02-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216786-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2024-02-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216786-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2024-02-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216786-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2024-02-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216786-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2024-02-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216786-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2024-02-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216786-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2024-02-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216786-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2024-02-01 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216786-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2024-02-01 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216786-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2024-02-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216786-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2024-02-01 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216786-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2024-02-01 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216786-001 METHSCOPOLAMINE BROMIDE 2.5MG TABLET / ORAL AA 2024-02-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216786-002 METHSCOPOLAMINE BROMIDE 5MG TABLET / ORAL AA 2024-02-01 a50c72e98297…
Observed Orange Book normalized TE history# 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 72319-030-02 METHSCOPOLAMINE BROMIDE 60 in 1 BOTTLE TABLET 60 3 72319-030-06 METHSCOPOLAMINE BROMIDE 1000 in 1 BOTTLE TABLET 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72319-030 METHSCOPOLAMINE BROMIDE TABLET [I3 PHARMACEUTICALS, LLC] 3 Current NDC, 2 package rows 20250227_14c0c030-e96d-4a5e-95ff-02dd78a46be3.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 Sample Exclude flag Status 72319-030-02 72319003002 60 TABLET in 1 BOTTLE (72319-030-02) 60 tablet 2024-12-18 No No Current 72319-030-06 72319003006 1000 TABLET in 1 BOTTLE (72319-030-06) 1000 tablet 2024-12-18 No No Current