Scopolamine

Product NDC: 0378-6470
11-digit product format: 003786470
Labeler code: 0378
Product ID: 0378-6470_79930eea-4bac-4412-871f-5cd0933bef05
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: scopolamine
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: Mylan Pharmaceuticals Inc.
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
163accb7-45e6-4d97-844d-72b606677008	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
0378-6470-16	Scopolamine	3 d in 1 PATCH	PATCH	3	7
0378-6470-16	Scopolamine	1 in 1 POUCH	PATCH	1	7
0378-6470-44	Scopolamine	1 in 1 POUCH	PATCH	1	7
0378-6470-44	Scopolamine	24 in 1 CARTON	PATCH	24	7
0378-6470-97	Scopolamine	10 in 1 CARTON	PATCH	10	7
0378-6470-97	Scopolamine	1 in 1 POUCH	PATCH	1	7
0378-6470-99	Scopolamine	4 in 1 CARTON	PATCH	4	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-6470-16	EA - Each	0378-6470	51a44ff4-9f40-4684-9d50-3220b44be769	1	2019-07-02
0378-6470-44	EA - Each	0378-6470	f743f108-b546-4a91-9d15-25ad00b934ae	1	2019-07-02
0378-6470-97	EA - Each	0378-6470	8fa83f65-4df1-44de-ba6a-40ece23a1360	1	2019-07-02
0378-6470-99	EA - Each	0378-6470	ad908584-6357-45f6-8b39-33066a341cc9	1	2019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-6470	SCOPOLAMINE PATCH [MYLAN PHARMACEUTICALS INC.]	4	Current NDC, Legacy NDC, 7 package rows	20250523_163accb7-45e6-4d97-844d-72b606677008.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 ndc (product): 0378-6470
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

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	163accb7-45e6-4d97-844d-72b606677008	7
226552	72 HR scopolamine 0.0139 MG/HR Transdermal System	SCD	163accb7-45e6-4d97-844d-72b606677008	7
226552	scopolamine 0.0139 MG/HR 72 HR Transdermal Patch	SY	163accb7-45e6-4d97-844d-72b606677008	7
226552	scopolamine 0.3336 MG/Day 72 HR Transdermal Patch	SY	163accb7-45e6-4d97-844d-72b606677008	7
226552	scopolamine 1.3 MG 3 Day Transdermal System	SY	163accb7-45e6-4d97-844d-72b606677008	7
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
0378-6470-16	00378647016	3 d in 1 PATCH	3 d					Historical
0378-6470-44	00378647044	24 POUCH in 1 CARTON (0378-6470-44) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH	24 pouch	2019-06-19	0000-00-00	No	No	Current
0378-6470-97	00378647097	10 POUCH in 1 CARTON (0378-6470-97) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH	10 pouch	2019-06-19	0000-00-00	No	No	Current
0378-6470-99	00378647099	4 POUCH in 1 CARTON (0378-6470-99) / 1 PATCH in 1 POUCH (0378-6470-16) / 3 d in 1 PATCH	4 pouch	2019-06-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Scopolamine - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2025-07-08	HUMAN PRESCRIPTION DRUG LABEL	7
Scopolamine - A-S Medication Solutions	A-S Medication Solutions	2023-07-21	HUMAN PRESCRIPTION DRUG LABEL	6