Scopolamine

Product NDC: 50742-505
11-digit product format: 507420505
Labeler code: 50742
Product ID: 50742-505_4c2816f0-78a7-476c-baa3-438d3873a92c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Scopolamine
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Ingenus Pharmaceuticals, LLC
Application: ANDA212342
Marketing category: ANDA
Marketing start: 2020-11-24
Substance: SCOPOLAMINE
Active strength: 1.5 mg/1
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 42.

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
A212342-001	SCOPOLAMINE	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RS	2020-11-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212342-001	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
2026-08-18 06:07:40	2026-07	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RS	2020-11-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RS	2020-11-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RS	2020-11-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RS	2020-11-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212342-001	SCOPOLAMINE	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-11-24	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2020-11-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212342-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RS	2020-11-24	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212342-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212342-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212342-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212342-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212342-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212342-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212342-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212342-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212342-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212342-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212342-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212342-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212342-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212342-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212342-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212342-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212342-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212342-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212342-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212342-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212342-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212342-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212342-001	AB	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212342-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212342-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212342-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212342-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212342-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212342-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212342-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212342-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212342-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212342-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212342-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212342-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212342-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212342-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Scopolamine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SCOPOLAMINE	1.5 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
2a6f9aaf-a70a-481f-a82b-1dcaaadc185b	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
50742-505-04	Scopolamine	1 in 1 POUCH	PATCH, EXTENDED RELEASE	1	12
50742-505-04	Scopolamine	4 in 1 CARTON	PATCH, EXTENDED RELEASE	4	12
50742-505-10	Scopolamine	10 in 1 CARTON	PATCH, EXTENDED RELEASE	10	12
50742-505-10	Scopolamine	1 in 1 POUCH	PATCH, EXTENDED RELEASE	1	12
50742-505-24	Scopolamine	1 in 1 POUCH	PATCH, EXTENDED RELEASE	1	12
50742-505-24	Scopolamine	24 in 1 CARTON	PATCH, EXTENDED RELEASE	24	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50742-505	SCOPOLAMINE PATCH, EXTENDED RELEASE [INGENUS PHARMACEUTICALS, LLC]	8	Current NDC, Legacy NDC, 6 package rows	20241003_2a6f9aaf-a70a-481f-a82b-1dcaaadc185b.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	NuCare Pharmaceuticals, Inc.	51289d8b-f7e3-a3e0-e063-6294a90add43	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212342 application number: ANDA212342
Scopolamine	SCOPOLAMINE	Ingenus Pharmaceuticals, LLC	2a6f9aaf-a70a-481f-a82b-1dcaaadc185b	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212342 application number: ANDA212342 ndc (product): 50742-505

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	2a6f9aaf-a70a-481f-a82b-1dcaaadc185b	12
226552	72 HR scopolamine 0.0139 MG/HR Transdermal System	SCD	2a6f9aaf-a70a-481f-a82b-1dcaaadc185b	12
226552	scopolamine 0.0139 MG/HR 72 HR Transdermal Patch	SY	2a6f9aaf-a70a-481f-a82b-1dcaaadc185b	12
226552	scopolamine 0.3336 MG/Day 72 HR Transdermal Patch	SY	2a6f9aaf-a70a-481f-a82b-1dcaaadc185b	12
226552	scopolamine 1.3 MG 3 Day Transdermal System	SY	2a6f9aaf-a70a-481f-a82b-1dcaaadc185b	12
226552	scopolamine 1 MG 3 Day Transdermal System	PSN	51289d8b-f7e3-a3e0-e063-6294a90add43	1
226552	72 HR scopolamine 0.0139 MG/HR Transdermal System	SCD	51289d8b-f7e3-a3e0-e063-6294a90add43	1
226552	scopolamine 0.0139 MG/HR 72 HR Transdermal Patch	SY	51289d8b-f7e3-a3e0-e063-6294a90add43	1
226552	scopolamine 0.3336 MG/Day 72 HR Transdermal Patch	SY	51289d8b-f7e3-a3e0-e063-6294a90add43	1
226552	scopolamine 1.3 MG 3 Day Transdermal System	SY	51289d8b-f7e3-a3e0-e063-6294a90add43	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50742-505-04	50742050504	4 POUCH in 1 CARTON (50742-505-04) / 1 PATCH, EXTENDED RELEASE in 1 POUCH	4 pouch	2020-11-24	0000-00-00	No	No	Current
50742-505-10	50742050510	10 POUCH in 1 CARTON (50742-505-10) / 1 PATCH, EXTENDED RELEASE in 1 POUCH	10 pouch	2020-11-24	0000-00-00	No	No	Current
50742-505-24	50742050524	24 POUCH in 1 CARTON (50742-505-24) / 1 PATCH, EXTENDED RELEASE in 1 POUCH	24 pouch	2020-11-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Scopolamine - NuCare Pharmaceuticals, Inc.	NuCare Pharmaceuticals, Inc.	2026-05-06	HUMAN PRESCRIPTION DRUG LABEL	1
Scopolamine - Ingenus Pharmaceuticals, LLC \| RICONPHARMA LLC \| Surmasis Pharmaceutical	Ingenus Pharmaceuticals, LLC \| RICONPHARMA LLC \| Surmasis Pharmaceutical	2025-12-04	HUMAN PRESCRIPTION DRUG LABEL	12