Mestinon

Product NDC: 0187-3012
11-digit product format: 001873012
Labeler code: 0187
Product ID: 0187-3012_f6bf0102-bf43-4f3b-8667-39362bc9cfbb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pyridostigmine bromide
Dosage form: SOLUTION
Route: ORAL
Labeler: Bausch Health US, LLC
Application: NDA015193
Marketing category: NDA
Marketing start: 1965-01-25
Substance: PYRIDOSTIGMINE BROMIDE
Active strength: 60 mg/5mL
Pharmacologic classes: Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [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
N015193-001	MESTINON	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N015193-001	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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N015193-001	MESTINON	60MG/5ML	SYRUP / ORAL	AA	RLD, RS, Approved before 1982	`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	N015193-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N015193-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N015193-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N015193-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N015193-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N015193-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N015193-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N015193-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N015193-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N015193-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N015193-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N015193-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N015193-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N015193-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N015193-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N015193-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N015193-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N015193-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N015193-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N015193-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N015193-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N015193-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N015193-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N015193-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N015193-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N015193-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N015193-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N015193-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N015193-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N015193-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N015193-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N015193-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N015193-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N015193-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N015193-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N015193-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N015193-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N015193-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N015193-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N015193-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Mestinon
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PYRIDOSTIGMINE BROMIDE	60 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
KVI301NA53	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
903843	Internal RxNorm lookup
903845	Internal RxNorm lookup
903847	Internal RxNorm lookup
903849	Internal RxNorm lookup
903857	Internal RxNorm lookup
903859	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
a851795e-b7a8-40c3-9922-5e79d3eb4d92	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cd6f4a37-8abf-2ed8-817f-5becdfa53ca5	Product name	9	20230112
dd640b44-88ec-4cbe-02c0-23127b95f5d3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0187-3012-20	Mestinon	473 mL in 1 BOTTLE	SOLUTION	473		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-3012-20	ML - Milliliter	0187-3012	ac3b7552-e144-4640-b614-bb9af39fd14c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
pyridostigmine bromide	ACTIVE INGREDIENT	KVI301NA53	MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	10
pyridostigmine	ACTIVE MOIETY	19QM69HH21	MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	10
alcohol	INACTIVE INGREDIENT	3K9958V90M	MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	10
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	10
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	10
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	10
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	10
lactic acid	INACTIVE INGREDIENT	33X04XA5AT	MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	10
lactose	INACTIVE INGREDIENT	J2B2A4N98G	MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	10
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	10
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	10
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	10
sorbitol	INACTIVE INGREDIENT	506T60A25R	MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	10
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	10
sucrose	INACTIVE INGREDIENT	C151H8M554	MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	10
tribasic calcium phosphate	INACTIVE INGREDIENT	91D9GV0Z28	MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	10
water	INACTIVE INGREDIENT	059QF0KO0R	MESTINON (PYRIDOSTIGMINE BROMIDE) SYRUP MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0187-3012	MESTINON (PYRIDOSTIGMINE BROMIDE) SOLUTION MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET MESTINON (PYRIDOSTIGMINE BROMIDE) TABLET, EXTENDED RELEASE [BAUSCH HEALTH US, LLC]	20	Current NDC, Legacy NDC, 1 package rows	20230202_a851795e-b7a8-40c3-9922-5e79d3eb4d92.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
pyridostigmine bromide	PYRIDOSTIGMINE BROMIDE	Oceanside Pharmaceuticals	970a0191-693c-480b-aeff-9f8956936159	2020-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 015193 application number: NDA015193
Mestinon	PYRIDOSTIGMINE BROMIDE	Bausch Health US, LLC	a851795e-b7a8-40c3-9922-5e79d3eb4d92	2020-12-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 015193 application number: NDA015193 ndc (product): 0187-3012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KVI301NA53	PYRIDOSTIGMINE BROMIDE	101-26-8	PYRIDOSTIGMINE BROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
903849	Mestinon 180 MG Extended Release Oral Tablet	PSN	a851795e-b7a8-40c3-9922-5e79d3eb4d92	20
903845	Mestinon 60 MG in 5 mL Oral Solution	PSN	a851795e-b7a8-40c3-9922-5e79d3eb4d92	20
903859	Mestinon 60 MG Oral Tablet	PSN	a851795e-b7a8-40c3-9922-5e79d3eb4d92	20
903847	pyRIDostigmine bromide 180 MG Extended Release Oral Tablet	PSN	a851795e-b7a8-40c3-9922-5e79d3eb4d92	20
903843	pyRIDostigmine bromide 60 MG in 5 mL Oral Solution	PSN	a851795e-b7a8-40c3-9922-5e79d3eb4d92	20
903857	pyRIDostigmine bromide 60 MG Oral Tablet	PSN	a851795e-b7a8-40c3-9922-5e79d3eb4d92	20
903845	pyridostigmine bromide 12 MG/ML Oral Solution [Mestinon]	SBD	a851795e-b7a8-40c3-9922-5e79d3eb4d92	20
903849	pyridostigmine bromide 180 MG Extended Release Oral Tablet [Mestinon]	SBD	a851795e-b7a8-40c3-9922-5e79d3eb4d92	20
903859	pyridostigmine bromide 60 MG Oral Tablet [Mestinon]	SBD	a851795e-b7a8-40c3-9922-5e79d3eb4d92	20
903843	pyridostigmine bromide 12 MG/ML Oral Solution	SCD	a851795e-b7a8-40c3-9922-5e79d3eb4d92	20
903847	pyridostigmine bromide 180 MG Extended Release Oral Tablet	SCD	a851795e-b7a8-40c3-9922-5e79d3eb4d92	20
903857	pyridostigmine bromide 60 MG Oral Tablet	SCD	a851795e-b7a8-40c3-9922-5e79d3eb4d92	20
903845	Mestinon 12 MG/ML Oral Solution	SY	a851795e-b7a8-40c3-9922-5e79d3eb4d92	20
903849	Mestinon 180 MG Extended Release Oral Tablet	SY	a851795e-b7a8-40c3-9922-5e79d3eb4d92	20
903849	Mestinon 180 MG Timespan Tablet	SY	a851795e-b7a8-40c3-9922-5e79d3eb4d92	20
903859	Mestinon 60 MG Oral Tablet	SY	a851795e-b7a8-40c3-9922-5e79d3eb4d92	20
903845	Mestinon 60 MG per 5 ML Syrup	SY	a851795e-b7a8-40c3-9922-5e79d3eb4d92	20
903843	pyridostigmine bromide 60 MG per 5 ML Oral Solution	SY	a851795e-b7a8-40c3-9922-5e79d3eb4d92	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-3012-20	00187301220	473 mL in 1 BOTTLE (0187-3012-20)	473 ml	1965-01-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MESTINON ® (pyridostigmine bromide) Oral Solution, USP ORAL SOLUTION TABLETS and TIMESPAN ® TABLETS	Bausch Health US, LLC \| Bausch Health Companies Inc.	2020-12-02	HUMAN PRESCRIPTION DRUG LABEL	20