Scopolamine Trandermal System

Product NDC: 63629-8450
11-digit product format: 636298450
Labeler code: 63629
Product ID: 63629-8450_6499b998-74f4-43c3-b2b6-79ea40ab474f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: scolopamine transdermal system
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Bryant Ranch Prepack
Application: ANDA078830
Marketing category: ANDA
Marketing start: 2017-06-13
Substance: SCOPOLAMINE
Active strength: 1 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078830-001	SCOPOLAMINE	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2015-01-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A078830-001	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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078830-001	SCOPOLAMINE	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078830-001	SCOPOLAMINE	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-01-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078830-001	SCOPOLAMINE	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-01-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078830-001	SCOPOLAMINE	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-01-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078830-001	SCOPOLAMINE	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-01-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078830-001	SCOPOLAMINE	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-01-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078830-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2015-01-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078830-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078830-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078830-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078830-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078830-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078830-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078830-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078830-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078830-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078830-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078830-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078830-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078830-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078830-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078830-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078830-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078830-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078830-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078830-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078830-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078830-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078830-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078830-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078830-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078830-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078830-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078830-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078830-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078830-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078830-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078830-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078830-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078830-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078830-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078830-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078830-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078830-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078830-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078830-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078830-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Scopolamine Trandermal System
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SCOPOLAMINE	1 mg/1

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c89cc74e-9506-48e5-bbb7-26b454b498aa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fe8ea78e-e1a4-44bf-a6b2-42eed76976bb	Product name	5	20250218

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-8450-1	Scopolamine Trandermal System	24 in 1 CARTON	PATCH, EXTENDED RELEASE	24		106
63629-8450-2	Scopolamine Trandermal System	1 in 1 POUCH	PATCH, EXTENDED RELEASE	1		106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8450-1	EA - Each	63629-8450	08b368ee-59ca-4440-a774-22cedc193e5e	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8450	SCOPOLAMINE TRANDERMAL SYSTEM (SCOLOPAMINE TRANSDERMAL SYSTEM) PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]	106	Current NDC, Legacy NDC, 2 package rows	20250316_c89cc74e-9506-48e5-bbb7-26b454b498aa.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Scopolamine Transdermal System	SCOPOLAMINE TRANSDERMAL SYSTEM	Bryant Ranch Prepack	8455ce88-1270-440b-b62e-fe5fef1415ac	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078830 application number: ANDA078830
Scopolamine Transdermal System	SCOPOLAMINE TRANSDERMAL SYSTEM	Padagis Israel Pharmaceuticals Ltd	cb93bfad-3e37-4a27-92f6-f21703ae7bdf	2025-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078830 application number: ANDA078830
Scopolamine Trandermal System	SCOLOPAMINE TRANSDERMAL SYSTEM	Bryant Ranch Prepack	81c57d46-1617-4295-8a60-acb7e365551c	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078830 application number: ANDA078830
Scopolamine Trandermal System	SCOLOPAMINE TRANSDERMAL SYSTEM	Bryant Ranch Prepack	1099a330-fcb8-4acd-9ef8-525024c6b9d6	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078830 application number: ANDA078830
Scopolamine Trandermal System	SCOLOPAMINE TRANSDERMAL SYSTEM	Bryant Ranch Prepack	c89cc74e-9506-48e5-bbb7-26b454b498aa	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078830 application number: ANDA078830 ndc (product): 63629-8450
Scopolamine Trandermal System	SCOLOPAMINE TRANSDERMAL SYSTEM	Bryant Ranch Prepack	69401d6f-3d18-48b0-b28c-a578c9834f32	2024-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078830 application number: ANDA078830

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
DL48G20X8X	SCOPOLAMINE	51-34-3	SCOPOLAMINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
226552	scopolamine 1 MG 3 Day Transdermal System	PSN	c89cc74e-9506-48e5-bbb7-26b454b498aa	106
226552	72 HR scopolamine 0.0139 MG/HR Transdermal System	SCD	c89cc74e-9506-48e5-bbb7-26b454b498aa	106
226552	scopolamine 0.0139 MG/HR 72 HR Transdermal Patch	SY	c89cc74e-9506-48e5-bbb7-26b454b498aa	106
226552	scopolamine 0.3336 MG/Day 72 HR Transdermal Patch	SY	c89cc74e-9506-48e5-bbb7-26b454b498aa	106
226552	scopolamine 1.3 MG 3 Day Transdermal System	SY	c89cc74e-9506-48e5-bbb7-26b454b498aa	106

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8450-1	63629845001	24 POUCH in 1 CARTON (63629-8450-1) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (63629-8450-2)	24 pouch	2024-04-04	0000-00-00	No	No	Current
63629-8450-2	63629845002	1 in 1 POUCH						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Scopolamine Trandermal System - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-05-30	HUMAN PRESCRIPTION DRUG LABEL	106