METHSCOPOLAMINE BROMIDE

Product NDC: 76385-101
11-digit product format: 763850101
Labeler code: 76385
Product ID: 76385-101_10a9a368-4ddc-4ffc-abfb-605c98fe1d97
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methscopolamine bromide
Dosage form: TABLET
Route: ORAL
Labeler: Unichem Pharmaceuticals (USA), Inc.
Application: ANDA200602
Marketing category: ANDA
Marketing start: 2013-10-01
Substance: METHSCOPOLAMINE BROMIDE
Active strength: 5 mg/1
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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A200602-001	METHSCOPOLAMINE BROMIDE	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET / ORAL	AA		2012-09-24
A200602-002	METHSCOPOLAMINE BROMIDE	METHSCOPOLAMINE BROMIDE	5MG	TABLET / ORAL	AA	RS	2012-09-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A200602-001	AA
A200602-002	AA

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 3 · 86 observed 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
2026-09-14 22:38:34	2026-08	A200602-001	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET / ORAL	AA		2012-09-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200602-002	METHSCOPOLAMINE BROMIDE	5MG	TABLET / ORAL	AA	RS	2012-09-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200602-001	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET / ORAL	AA		2012-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200602-002	METHSCOPOLAMINE BROMIDE	5MG	TABLET / ORAL	AA	RS	2012-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200602-001	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET / ORAL	AA		2012-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200602-002	METHSCOPOLAMINE BROMIDE	5MG	TABLET / ORAL	AA	RS	2012-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200602-001	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET / ORAL	AA		2012-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200602-002	METHSCOPOLAMINE BROMIDE	5MG	TABLET / ORAL	AA	RS	2012-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200602-001	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET / ORAL	AA		2012-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200602-002	METHSCOPOLAMINE BROMIDE	5MG	TABLET / ORAL	AA	RS	2012-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200602-001	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET / ORAL	AA		2012-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200602-002	METHSCOPOLAMINE BROMIDE	5MG	TABLET / ORAL	AA	RS	2012-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200602-001	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET / ORAL	AA		2012-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200602-002	METHSCOPOLAMINE BROMIDE	5MG	TABLET / ORAL	AA	RS	2012-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200602-001	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET / ORAL	AA		2012-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200602-002	METHSCOPOLAMINE BROMIDE	5MG	TABLET / ORAL	AA	RS	2012-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200602-001	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET / ORAL	AA		2012-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200602-002	METHSCOPOLAMINE BROMIDE	5MG	TABLET / ORAL	AA	RS	2012-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200602-001	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET / ORAL	AA		2012-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200602-002	METHSCOPOLAMINE BROMIDE	5MG	TABLET / ORAL	AA	RS	2012-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200602-001	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET / ORAL	AA		2012-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200602-002	METHSCOPOLAMINE BROMIDE	5MG	TABLET / ORAL	AA	RS	2012-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200602-001	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET / ORAL	AA		2012-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200602-002	METHSCOPOLAMINE BROMIDE	5MG	TABLET / ORAL	AA	RS	2012-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200602-001	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET / ORAL	AA		2012-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200602-002	METHSCOPOLAMINE BROMIDE	5MG	TABLET / ORAL	AA	RS	2012-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200602-001	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET / ORAL	AA		2012-09-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200602-002	METHSCOPOLAMINE BROMIDE	5MG	TABLET / ORAL	AA	RS	2012-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200602-001	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET / ORAL	AA		2012-09-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200602-002	METHSCOPOLAMINE BROMIDE	5MG	TABLET / ORAL	AA	RS	2012-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200602-001	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET / ORAL	AA		2012-09-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200602-002	METHSCOPOLAMINE BROMIDE	5MG	TABLET / ORAL	AA	RS	2012-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200602-001	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET / ORAL	AA		2012-09-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200602-002	METHSCOPOLAMINE BROMIDE	5MG	TABLET / ORAL	AA	RS	2012-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200602-001	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET / ORAL	AA		2012-09-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200602-002	METHSCOPOLAMINE BROMIDE	5MG	TABLET / ORAL	AA	RS	2012-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200602-001	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET / ORAL	AA		2012-09-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200602-002	METHSCOPOLAMINE BROMIDE	5MG	TABLET / ORAL	AA	RS	2012-09-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200602-001	METHSCOPOLAMINE BROMIDE	2.5MG	TABLET / ORAL			2012-09-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200602-002	METHSCOPOLAMINE BROMIDE	5MG	TABLET / ORAL		RS	2012-09-24	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A200602-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200602-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200602-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200602-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200602-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200602-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200602-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200602-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200602-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200602-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200602-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200602-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200602-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200602-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200602-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200602-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200602-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200602-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200602-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200602-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200602-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200602-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200602-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200602-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200602-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200602-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200602-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200602-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200602-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200602-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200602-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200602-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200602-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200602-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200602-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200602-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200602-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200602-002	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A200602-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200602-002	AA	1	`bb7c543d1eb4…`

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: METHSCOPOLAMINE BROMIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHSCOPOLAMINE BROMIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
RTN51LK7WL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
314088	Internal RxNorm lookup
403914	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
5c74bfb0-c80a-4a86-acd1-1e3a1b20255d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
62bf66cd-09d0-4b08-aa9d-7b67e1476683	Product name	2	20250114

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76385-101-60	METHSCOPOLAMINE BROMIDE	60 in 1 BOTTLE	TABLET	60		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76385-101-60	EA - Each	76385-101	8662f159-b793-4247-ad62-e23925905aae	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHSCOPOLAMINE BROMIDE	ACTIVE INGREDIENT	RTN51LK7WL	METHSCOPOLAMINE BROMIDE TABLET [BAYSHORE PHARMACEUTICALS LLC]	2
METHSCOPOLAMINE	ACTIVE MOIETY	VDR09VTQ8U	METHSCOPOLAMINE BROMIDE TABLET [BAYSHORE PHARMACEUTICALS LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METHSCOPOLAMINE BROMIDE TABLET [BAYSHORE PHARMACEUTICALS LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METHSCOPOLAMINE BROMIDE TABLET [BAYSHORE PHARMACEUTICALS LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METHSCOPOLAMINE BROMIDE TABLET [BAYSHORE PHARMACEUTICALS LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METHSCOPOLAMINE BROMIDE TABLET [BAYSHORE PHARMACEUTICALS LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76385-101	METHSCOPOLAMINE BROMIDE TABLET [BAYSHORE PHARMACEUTICALS LLC]	8	Current NDC, Legacy NDC, 1 package rows	20200127_5c74bfb0-c80a-4a86-acd1-1e3a1b20255d.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METHSCOPOLAMINE BROMIDE	METHSCOPOLAMINE BROMIDE	Bryant Ranch Prepack	4ee28ed4-daff-462c-a38b-4fd8250ed9f4	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200602 application number: ANDA200602
METHSCOPOLAMINE BROMIDE	METHSCOPOLAMINE BROMIDE	Bryant Ranch Prepack	6b8ed187-d378-4c95-80e0-0d3558a7aa95	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200602 application number: ANDA200602
METHSCOPOLAMINE BROMIDE	METHSCOPOLAMINE BROMIDE	PD-Rx Pharmaceuticals, Inc.	26cd56db-4727-40d1-8f08-3ee899052c77	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200602 application number: ANDA200602
METHSCOPOLAMINE BROMIDE	METHSCOPOLAMINE BROMIDE	PD-Rx Pharmaceuticals, Inc.	8a14ade6-d428-4144-9037-46955f68820f	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200602 application number: ANDA200602
METHSCOPOLAMINE BROMIDE	METHSCOPOLAMINE BROMIDE	Unichem Pharmaceuticals (USA), Inc.	5c74bfb0-c80a-4a86-acd1-1e3a1b20255d	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200602 application number: ANDA200602 ndc (product): 76385-101

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RTN51LK7WL	METHSCOPOLAMINE BROMIDE	155-41-9	METHSCOPOLAMINE BROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
403914	methscopolamine bromide 5 MG Oral Tablet	PSN	6b8ed187-d378-4c95-80e0-0d3558a7aa95	101
403914	methscopolamine bromide 5 MG Oral Tablet	SCD	6b8ed187-d378-4c95-80e0-0d3558a7aa95	101
403914	methscopolamine bromide 5 MG Oral Tablet	PSN	8a14ade6-d428-4144-9037-46955f68820f	11
403914	methscopolamine bromide 5 MG Oral Tablet	SCD	8a14ade6-d428-4144-9037-46955f68820f	11
314088	methscopolamine bromide 2.5 MG Oral Tablet	PSN	5c74bfb0-c80a-4a86-acd1-1e3a1b20255d	9
403914	methscopolamine bromide 5 MG Oral Tablet	PSN	5c74bfb0-c80a-4a86-acd1-1e3a1b20255d	9
314088	methscopolamine bromide 2.5 MG Oral Tablet	SCD	5c74bfb0-c80a-4a86-acd1-1e3a1b20255d	9
403914	methscopolamine bromide 5 MG Oral Tablet	SCD	5c74bfb0-c80a-4a86-acd1-1e3a1b20255d	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76385-101-60	76385010160	60 TABLET in 1 BOTTLE (76385-101-60)	60 tablet	2013-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methscopolamine Bromide Tablets, USP 2.5 mg and 5 mg Rx Only	Bryant Ranch Prepack	2026-03-13	HUMAN PRESCRIPTION DRUG LABEL	101
Methscopolamine Bromide Tablets, USP 5 mg Rx Only	PD-Rx Pharmaceuticals, Inc.	2026-01-05	HUMAN PRESCRIPTION DRUG LABEL	11
Methscopolamine Bromide Tablets, USP 2.5 mg and 5 mg Rx Only	Unichem Pharmaceuticals (USA), Inc. \| Unichem Laboratories Limited, India \| Sunrise Pharmaceutical, INC.	2025-12-10	HUMAN PRESCRIPTION DRUG LABEL	9