Scopolamine

Product NDC: 50090-5349
11-digit product format: 500905349
Labeler code: 50090
Product ID: 50090-5349_0d975b5a-2168-45c5-8c36-d28210d84161
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: scopolamine
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: A-S Medication Solutions
Application: ANDA203753
Marketing category: ANDA
Marketing start: 2019-06-19
Substance: SCOPOLAMINE
Active strength: 1 mg/3d
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
A203753-001	SCOPOLAMINE	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2019-06-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203753-001	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	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203753-001	SCOPOLAMINE	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-06-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203753-001	SCOPOLAMINE	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-06-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203753-001	SCOPOLAMINE	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-06-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203753-001	SCOPOLAMINE	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-06-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203753-001	SCOPOLAMINE	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-06-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203753-001	SCOPOLAMINE	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-06-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203753-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2019-06-19	`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	A203753-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203753-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203753-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203753-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203753-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203753-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203753-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203753-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203753-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203753-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203753-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203753-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203753-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203753-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203753-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203753-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203753-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203753-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203753-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203753-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203753-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203753-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203753-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203753-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203753-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203753-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203753-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203753-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203753-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203753-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203753-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203753-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203753-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203753-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203753-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203753-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203753-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203753-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203753-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203753-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b24c2315-c947-4ad2-89fe-8dc0c45e221b	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-5349-0	2023-02-07	C162847	48780-1	f386c649-dc96-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use SCOPOLAMINE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for SCOPOLAMINE TRANSDERMAL SYSTEM . SCOPOLAMINE transdermal system Initial U.S. Approval: 1979
50090-5349-0	2023-01-30	C162847	48780-1	f386c649-dc96-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use SCOPOLAMINE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for SCOPOLAMINE TRANSDERMAL SYSTEM . SCOPOLAMINE transdermal system Initial U.S. Approval: 1979

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-5349-0	Scopolamine	1 d in 1 POUCH	PATCH	1		6
50090-5349-0	Scopolamine	4 in 1 CARTON	PATCH	4		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5349-0	EA - Each	50090-5349	4c1eee4b-e1da-4e42-a403-ff7b02c2c207	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5349	SCOPOLAMINE PATCH [A-S MEDICATION SOLUTIONS]	6	Current NDC, Legacy NDC, 2 package rows	20230722_b24c2315-c947-4ad2-89fe-8dc0c45e221b.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Scopolamine	SCOPOLAMINE	Mylan Pharmaceuticals Inc.	163accb7-45e6-4d97-844d-72b606677008	2025-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203753 application number: ANDA203753
Scopolamine	SCOPOLAMINE	A-S Medication Solutions	b24c2315-c947-4ad2-89fe-8dc0c45e221b	2023-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203753 application number: ANDA203753 ndc (product): 50090-5349

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	b24c2315-c947-4ad2-89fe-8dc0c45e221b	6
226552	72 HR scopolamine 0.0139 MG/HR Transdermal System	SCD	b24c2315-c947-4ad2-89fe-8dc0c45e221b	6
226552	scopolamine 0.0139 MG/HR 72 HR Transdermal Patch	SY	b24c2315-c947-4ad2-89fe-8dc0c45e221b	6
226552	scopolamine 0.3336 MG/Day 72 HR Transdermal Patch	SY	b24c2315-c947-4ad2-89fe-8dc0c45e221b	6
226552	scopolamine 1.3 MG 3 Day Transdermal System	SY	b24c2315-c947-4ad2-89fe-8dc0c45e221b	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5349-0	50090534900	4 POUCH in 1 CARTON (50090-5349-0) / 1 d in 1 POUCH	4 pouch	2020-11-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Scopolamine - A-S Medication Solutions	A-S Medication Solutions	2023-07-21	HUMAN PRESCRIPTION DRUG LABEL	6