scopolamine

Product NDC: 0591-2258
11-digit product format: 005912258
Labeler code: 0591
Product ID: 0591-2258_59f10193-3604-4f3c-a9f7-68a55004f3d0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: scopolamine
Dosage form: SYSTEM
Route: TRANSDERMAL
Labeler: Actavis Pharma, Inc.
Application: ANDA208769
Marketing category: ANDA
Marketing start: 2022-05-12
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
A208769-001	SCOPOLAMINE	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2022-01-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208769-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208769-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2022-01-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208769-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208769-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208769-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208769-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208769-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208769-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208769-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208769-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208769-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208769-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208769-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208769-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208769-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208769-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208769-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208769-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208769-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208769-001	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208769-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208769-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208769-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208769-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208769-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208769-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208769-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208769-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208769-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208769-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208769-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208769-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208769-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208769-001	AB	1	`a50c72e98297…`

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
800b6421-48eb-47f5-b255-c12f75e59068	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
0591-2258-04	scopolamine	4 in 1 CARTON	SYSTEM	4	4
0591-2258-04	scopolamine	1 in 1 POUCH	SYSTEM	1	4
0591-2258-23	scopolamine	1 in 1 POUCH	SYSTEM	1	4
0591-2258-23	scopolamine	24 in 1 CARTON	SYSTEM	24	4
0591-2258-79	scopolamine	1 in 1 POUCH	SYSTEM	1	4
0591-2258-79	scopolamine	10 in 1 CARTON	SYSTEM	10	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-2258-04	EA - Each	0591-2258	8582207d-925e-402b-9667-5fec5abd14a1	1	2022-06-06
0591-2258-23	EA - Each	0591-2258	ccfd53da-8a48-4e7a-806d-426f19b49521	1	2022-06-06
0591-2258-79	EA - Each	0591-2258	2319f4d1-ddd5-4747-baec-d34b3c77110e	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-2258	SCOPOLAMINE SYSTEM [ACTAVIS PHARMA, INC.]	3	Current NDC, Legacy NDC, 6 package rows	20240905_800b6421-48eb-47f5-b255-c12f75e59068.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	Actavis Pharma, Inc.	800b6421-48eb-47f5-b255-c12f75e59068	2025-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208769 application number: ANDA208769 ndc (product): 0591-2258
scopolamine	SCOPOLAMINE	A-S Medication Solutions	5c232a94-0842-4efc-98a6-9d23e3b15a76	2024-07-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208769 application number: ANDA208769

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	800b6421-48eb-47f5-b255-c12f75e59068	4
226552	72 HR scopolamine 0.0139 MG/HR Transdermal System	SCD	800b6421-48eb-47f5-b255-c12f75e59068	4
226552	scopolamine 0.0139 MG/HR 72 HR Transdermal Patch	SY	800b6421-48eb-47f5-b255-c12f75e59068	4
226552	scopolamine 0.3336 MG/Day 72 HR Transdermal Patch	SY	800b6421-48eb-47f5-b255-c12f75e59068	4
226552	scopolamine 1.3 MG 3 Day Transdermal System	SY	800b6421-48eb-47f5-b255-c12f75e59068	4
226552	scopolamine 1 MG 3 Day Transdermal System	PSN	5c232a94-0842-4efc-98a6-9d23e3b15a76	3
226552	72 HR scopolamine 0.0139 MG/HR Transdermal System	SCD	5c232a94-0842-4efc-98a6-9d23e3b15a76	3
226552	scopolamine 0.0139 MG/HR 72 HR Transdermal Patch	SY	5c232a94-0842-4efc-98a6-9d23e3b15a76	3
226552	scopolamine 0.3336 MG/Day 72 HR Transdermal Patch	SY	5c232a94-0842-4efc-98a6-9d23e3b15a76	3
226552	scopolamine 1.3 MG 3 Day Transdermal System	SY	5c232a94-0842-4efc-98a6-9d23e3b15a76	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-2258-04	00591225804	4 POUCH in 1 CARTON (0591-2258-04) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH	4 pouch	2022-05-12	0000-00-00	No	No	Current
0591-2258-23	00591225823	24 POUCH in 1 CARTON (0591-2258-23) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH	24 pouch	2022-05-12	0000-00-00	No	No	Current
0591-2258-79	00591225879	10 POUCH in 1 CARTON (0591-2258-79) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH	10 pouch	2022-05-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
scopolamine - Actavis Pharma, Inc.	Actavis Pharma, Inc.	2025-06-12	HUMAN PRESCRIPTION DRUG LABEL	4
scopolamine - A-S Medication Solutions	A-S Medication Solutions	2024-07-05	HUMAN PRESCRIPTION DRUG LABEL	3