Scopolamine Transdermal System

Product NDC: 45802-580
11-digit product format: 458020580
Labeler code: 45802
Product ID: 45802-580_d334a21d-7546-477f-a66a-f95b2cf523ce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: scopolamine transdermal system
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA078830
Marketing category: ANDA
Marketing start: 2017-06-13
Marketing end: 2028-06-30
Substance: SCOPOLAMINE
Active strength: 1 mg/1
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	45802-580	45802-580-01	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45802-580	45802-580-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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 Transdermal System

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
cb93bfad-3e37-4a27-92f6-f21703ae7bdf	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	SPL version
45802-580-01	Scopolamine Transdermal System	1 in 1 POUCH	PATCH, EXTENDED RELEASE	1	12
45802-580-46	Scopolamine Transdermal System	1 in 1 POUCH	PATCH, EXTENDED RELEASE	1	12
45802-580-46	Scopolamine Transdermal System	10 in 1 CARTON	PATCH, EXTENDED RELEASE	10	12
45802-580-62	Scopolamine Transdermal System	1 in 1 POUCH	PATCH, EXTENDED RELEASE	1	12
45802-580-62	Scopolamine Transdermal System	24 in 1 CARTON	PATCH, EXTENDED RELEASE	24	12
45802-580-84	Scopolamine Transdermal System	1 in 1 POUCH	PATCH, EXTENDED RELEASE	1	12
45802-580-84	Scopolamine Transdermal System	4 in 1 CARTON	PATCH, EXTENDED RELEASE	4	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-580-01	EA - Each	45802-580	36538346-8445-40ce-88f8-85f6765f27fb	1	2017-09-11
45802-580-46	EA - Each	45802-580	8e23ad05-ae60-41ec-96ae-3c8ea7555c68	1	2017-08-11
45802-580-62	EA - Each	45802-580	c0827981-ceff-43c9-9627-7005144347a6	1	2017-08-11
45802-580-84	EA - Each	45802-580	06c2c56b-451d-40c7-8a89-2194ebc83c10	1	2017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-580	SCOPOLAMINE TRANSDERMAL SYSTEM (SCOLOPAMINE TRANSDERMAL SYSTEM) PATCH, EXTENDED RELEASE [PADAGIS ISRAEL PHARMACEUTICALS LTD]	9	Current NDC, Legacy NDC, 7 package rows	20240405_cb93bfad-3e37-4a27-92f6-f21703ae7bdf.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 ndc (product): 45802-580
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
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	1099a330-fcb8-4acd-9ef8-525024c6b9d6	107
226552	72 HR scopolamine 0.0139 MG/HR Transdermal System	SCD	1099a330-fcb8-4acd-9ef8-525024c6b9d6	107
226552	scopolamine 0.0139 MG/HR 72 HR Transdermal Patch	SY	1099a330-fcb8-4acd-9ef8-525024c6b9d6	107
226552	scopolamine 0.3336 MG/Day 72 HR Transdermal Patch	SY	1099a330-fcb8-4acd-9ef8-525024c6b9d6	107
226552	scopolamine 1.3 MG 3 Day Transdermal System	SY	1099a330-fcb8-4acd-9ef8-525024c6b9d6	107
226552	scopolamine 1 MG 3 Day Transdermal System	PSN	81c57d46-1617-4295-8a60-acb7e365551c	106
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	72 HR scopolamine 0.0139 MG/HR Transdermal System	SCD	81c57d46-1617-4295-8a60-acb7e365551c	106
226552	scopolamine 0.0139 MG/HR 72 HR Transdermal Patch	SY	81c57d46-1617-4295-8a60-acb7e365551c	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	81c57d46-1617-4295-8a60-acb7e365551c	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	81c57d46-1617-4295-8a60-acb7e365551c	106
226552	scopolamine 1.3 MG 3 Day Transdermal System	SY	c89cc74e-9506-48e5-bbb7-26b454b498aa	106
226552	scopolamine 1 MG 3 Day Transdermal System	PSN	69401d6f-3d18-48b0-b28c-a578c9834f32	104
226552	72 HR scopolamine 0.0139 MG/HR Transdermal System	SCD	69401d6f-3d18-48b0-b28c-a578c9834f32	104
226552	scopolamine 0.0139 MG/HR 72 HR Transdermal Patch	SY	69401d6f-3d18-48b0-b28c-a578c9834f32	104
226552	scopolamine 0.3336 MG/Day 72 HR Transdermal Patch	SY	69401d6f-3d18-48b0-b28c-a578c9834f32	104
226552	scopolamine 1.3 MG 3 Day Transdermal System	SY	69401d6f-3d18-48b0-b28c-a578c9834f32	104
226552	scopolamine 1 MG 3 Day Transdermal System	PSN	8455ce88-1270-440b-b62e-fe5fef1415ac	101
226552	72 HR scopolamine 0.0139 MG/HR Transdermal System	SCD	8455ce88-1270-440b-b62e-fe5fef1415ac	101
226552	scopolamine 0.0139 MG/HR 72 HR Transdermal Patch	SY	8455ce88-1270-440b-b62e-fe5fef1415ac	101
226552	scopolamine 0.3336 MG/Day 72 HR Transdermal Patch	SY	8455ce88-1270-440b-b62e-fe5fef1415ac	101
226552	scopolamine 1.3 MG 3 Day Transdermal System	SY	8455ce88-1270-440b-b62e-fe5fef1415ac	101
226552	scopolamine 1 MG 3 Day Transdermal System	PSN	cb93bfad-3e37-4a27-92f6-f21703ae7bdf	12
226552	72 HR scopolamine 0.0139 MG/HR Transdermal System	SCD	cb93bfad-3e37-4a27-92f6-f21703ae7bdf	12
226552	scopolamine 0.0139 MG/HR 72 HR Transdermal Patch	SY	cb93bfad-3e37-4a27-92f6-f21703ae7bdf	12
226552	scopolamine 0.3336 MG/Day 72 HR Transdermal Patch	SY	cb93bfad-3e37-4a27-92f6-f21703ae7bdf	12
226552	scopolamine 1.3 MG 3 Day Transdermal System	SY	cb93bfad-3e37-4a27-92f6-f21703ae7bdf	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-580-01	45802058001	1 PATCH, EXTENDED RELEASE in 1 POUCH (45802-580-01)		2017-06-13	0000-00-00	No	No	Current
45802-580-46	45802058046	10 POUCH in 1 CARTON (45802-580-46) / 1 PATCH, EXTENDED RELEASE in 1 POUCH	10 pouch	2017-06-13	2028-06-30	No	No	Current
45802-580-62	45802058062	24 POUCH in 1 CARTON (45802-580-62) / 1 PATCH, EXTENDED RELEASE in 1 POUCH	24 pouch	2017-06-13	2028-06-30	No	No	Current
45802-580-84	45802058084	4 POUCH in 1 CARTON (45802-580-84) / 1 PATCH, EXTENDED RELEASE in 1 POUCH	4 pouch	2017-06-13	2028-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Scopolamine Transdermal System - Bryant Ranch Prepack	Bryant Ranch Prepack	2025-07-31	HUMAN PRESCRIPTION DRUG LABEL	101
Scopolamine Transdermal System - Padagis Israel Pharmaceuticals Ltd	Padagis Israel Pharmaceuticals Ltd	2025-05-31	HUMAN PRESCRIPTION DRUG LABEL	12
Scopolamine Trandermal System - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-06-05	HUMAN PRESCRIPTION DRUG LABEL	106
Scopolamine Trandermal System - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-05-30	HUMAN PRESCRIPTION DRUG LABEL	107
Scopolamine Trandermal System - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-05-30	HUMAN PRESCRIPTION DRUG LABEL	106
Scopolamine Trandermal System - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-01-05	HUMAN PRESCRIPTION DRUG LABEL	104