Pyridostigmine Bromide

Product NDC: 42192-626
11-digit product format: 421920626
Labeler code: 42192
Product ID: 42192-626_40422b8d-3f5d-6590-e063-6394a90a1532
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pyridostigmine bromide
Dosage form: SOLUTION
Route: ORAL
Labeler: Acella Pharmaceuticals, LLC
Application: ANDA212405
Marketing category: ANDA
Marketing start: 2023-10-09
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
A212405-001	PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA		2022-04-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212405-001	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.

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	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL		2022-04-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212405-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2022-04-19	`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	A212405-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212405-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212405-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212405-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212405-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212405-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212405-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212405-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212405-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212405-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212405-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212405-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212405-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212405-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212405-001	AA	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212405-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212405-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212405-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212405-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212405-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212405-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212405-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212405-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212405-001	AA	1	`3bdfa0b2c4d7…`
2022-10-28 04:53 UTC	2022-10	A212405-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212405-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212405-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212405-001	AA	1	`a50c72e98297…`

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
903843	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
56999559-274e-44ea-a317-29366fdca908	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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
dd640b44-88ec-4cbe-02c0-23127b95f5d3	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42192-626-16	Pyridostigmine Bromide	473 mL in 1 BOTTLE	SOLUTION	473		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42192-626-16	ML - Milliliter	42192-626	4acd67ca-ac8a-4af3-aed6-03599c497b54	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42192-626	PYRIDOSTIGMINE BROMIDE SOLUTION [ACELLA PHARMACEUTICALS, LLC]	2	Current NDC, 1 package rows	20241011_56999559-274e-44ea-a317-29366fdca908.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Acella Pharmaceuticals, LLC	56999559-274e-44ea-a317-29366fdca908	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212405 application number: ANDA212405 ndc (product): 42192-626

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
903843	pyRIDostigmine bromide 60 MG in 5 mL Oral Solution	PSN	56999559-274e-44ea-a317-29366fdca908	3
903843	pyridostigmine bromide 12 MG/ML Oral Solution	SCD	56999559-274e-44ea-a317-29366fdca908	3
903843	pyridostigmine bromide 60 MG per 5 ML Oral Solution	SY	56999559-274e-44ea-a317-29366fdca908	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42192-626-16	42192062616	473 mL in 1 BOTTLE (42192-626-16)	473 ml	2023-10-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pyridostigmine Bromide Oral Solution USP	Acella Pharmaceuticals, LLC	2026-07-10	HUMAN PRESCRIPTION DRUG LABEL	4