Scopolamine

Product NDC: 71335-3015
11-digit product format: 713353015
Labeler code: 71335
Product ID: 71335-3015_19e67329-9b01-4f9c-892c-88127bb075e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Scopolamine
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Bryant Ranch Prepack
Application: ANDA215329
Marketing category: ANDA
Marketing start: 2024-11-01
Substance: SCOPOLAMINE
Active strength: 1 mg/3d
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 43.

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
A215329-001	SCOPOLAMINE	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB		2024-05-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215329-001	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
2026-09-14 22:38:34	2026-08	A215329-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2024-05-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215329-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2024-05-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215329-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2024-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215329-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2024-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215329-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2024-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215329-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2024-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215329-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2024-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215329-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2024-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215329-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2024-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215329-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2024-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215329-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2024-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215329-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2024-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215329-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2024-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215329-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2024-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215329-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2024-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215329-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2024-05-06	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215329-001	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	2024-05-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215329-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215329-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215329-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215329-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215329-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215329-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215329-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215329-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215329-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215329-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215329-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215329-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215329-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215329-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215329-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215329-001	AB	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215329-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

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
5aa64f85-ae52-4a86-a894-a4e536fbe4ad	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
71335-3015-1	Scopolamine	1 in 1 POUCH	PATCH, EXTENDED RELEASE	1		101
71335-3015-1	Scopolamine	24 in 1 BOX	PATCH, EXTENDED RELEASE	24		101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-3015-1	EA - Each	71335-3015	5bf065d0-59bd-4f31-b0bc-5ffd7af7b5fc	1	2026-01-08

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Scopolamine	SCOPOLAMINE	Rhodes Pharmaceuticals LLC	ba5a1237-4d23-441a-808e-96b97045fbe2	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215329 application number: ANDA215329
Scopolamine	SCOPOLAMINE	Bryant Ranch Prepack	5aa64f85-ae52-4a86-a894-a4e536fbe4ad	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215329 application number: ANDA215329 ndc (product): 71335-3015
Scopolamine	SCOPOLAMINE	Bryant Ranch Prepack	dd031a59-6b8c-49b1-9b4d-e7a7b75e3801	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215329 application number: ANDA215329
Scopolamine	SCOPOLAMINE	Bryant Ranch Prepack	8d53ee59-e0ef-4332-a6d6-0ac5a6c21b55	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215329 application number: ANDA215329
Scopolamine	SCOPOLAMINE	Bryant Ranch Prepack	a472ee74-76a7-470f-8564-9018940a82e8	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215329 application number: ANDA215329

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	5aa64f85-ae52-4a86-a894-a4e536fbe4ad	101
226552	72 HR scopolamine 0.0139 MG/HR Transdermal System	SCD	5aa64f85-ae52-4a86-a894-a4e536fbe4ad	101
226552	scopolamine 0.0139 MG/HR 72 HR Transdermal Patch	SY	5aa64f85-ae52-4a86-a894-a4e536fbe4ad	101
226552	scopolamine 0.3336 MG/Day 72 HR Transdermal Patch	SY	5aa64f85-ae52-4a86-a894-a4e536fbe4ad	101
226552	scopolamine 1.3 MG 3 Day Transdermal System	SY	5aa64f85-ae52-4a86-a894-a4e536fbe4ad	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-3015-1	71335301501	24 POUCH in 1 BOX (71335-3015-1) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH	24 pouch	2025-11-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Scopolamine - Bryant Ranch Prepack	Bryant Ranch Prepack	2026-04-16	HUMAN PRESCRIPTION DRUG LABEL	101