Home NDC 72162-2453 Scopolamine
Product NDC 72162-2453
11-digit product format 721622453
Labeler code 72162
Product ID 72162-2453_4a095aed-7863-4738-8619-04b10bcfeb6c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Scopolamine
Dosage form PATCH, EXTENDED RELEASE
Route TRANSDERMAL
Labeler Bryant Ranch Prepack
Application ANDA215329
Marketing category ANDA
Marketing start 2024-11-01
Substance SCOPOLAMINE
Active strength 1 mg/3d
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215329-001 SCOPOLAMINE SCOPOLAMINE 1MG/72HR SYSTEM / TRANSDERMAL AB 2024-05-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215329-001 AB
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 A215329-001 SCOPOLAMINE 1MG/72HR SYSTEM / TRANSDERMAL AB 2024-05-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215329-001 SCOPOLAMINE 1MG/72HR SYSTEM / TRANSDERMAL AB 2024-05-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215329-001 SCOPOLAMINE 1MG/72HR SYSTEM / TRANSDERMAL AB 2024-05-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215329-001 SCOPOLAMINE 1MG/72HR SYSTEM / TRANSDERMAL AB 2024-05-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215329-001 SCOPOLAMINE 1MG/72HR SYSTEM / TRANSDERMAL AB 2024-05-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215329-001 SCOPOLAMINE 1MG/72HR SYSTEM / TRANSDERMAL AB 2024-05-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215329-001 SCOPOLAMINE 1MG/72HR SYSTEM / TRANSDERMAL AB 2024-05-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215329-001 SCOPOLAMINE 1MG/72HR SYSTEM / TRANSDERMAL AB 2024-05-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215329-001 SCOPOLAMINE 1MG/72HR SYSTEM / TRANSDERMAL AB 2024-05-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215329-001 SCOPOLAMINE 1MG/72HR SYSTEM / TRANSDERMAL AB 2024-05-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215329-001 SCOPOLAMINE 1MG/72HR SYSTEM / TRANSDERMAL AB 2024-05-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215329-001 SCOPOLAMINE 1MG/72HR SYSTEM / TRANSDERMAL AB 2024-05-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215329-001 SCOPOLAMINE 1MG/72HR SYSTEM / TRANSDERMAL AB 2024-05-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215329-001 SCOPOLAMINE 1MG/72HR SYSTEM / TRANSDERMAL AB 2024-05-06 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215329-001 SCOPOLAMINE 1MG/72HR SYSTEM / TRANSDERMAL AB 2024-05-06 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Scopolamine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SCOPOLAMINE 1 mg/3d
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DL48G20X8X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 226552 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 72162-2453-2 Scopolamine 1 in 1 POUCH PATCH, EXTENDED RELEASE 1 102 72162-2453-2 Scopolamine 4 in 1 BOX PATCH, EXTENDED RELEASE 4 102 72162-2453-4 Scopolamine 10 in 1 BOX PATCH, EXTENDED RELEASE 10 102 72162-2453-4 Scopolamine 1 in 1 POUCH PATCH, EXTENDED RELEASE 1 102 72162-2453-7 Scopolamine 24 in 1 BOX PATCH, EXTENDED RELEASE 24 102 72162-2453-7 Scopolamine 1 in 1 POUCH PATCH, EXTENDED RELEASE 1 102
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-2453 SCOPOLAMINE PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK] 100 Current NDC, 6 package rows 20250130_a472ee74-76a7-470f-8564-9018940a82e8.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72162-2453-2 72162245302 4 POUCH in 1 BOX (72162-2453-2) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH 4 pouch 2025-01-28 No No Current 72162-2453-4 72162245304 10 POUCH in 1 BOX (72162-2453-4) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH 10 pouch 2025-01-28 No No Current 72162-2453-7 72162245307 24 POUCH in 1 BOX (72162-2453-7) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH 24 pouch 2025-01-28 No No Current