Pyridostigmine

Product NDC: 70954-148
11-digit product format: 709540148
Labeler code: 70954
Product ID: 70954-148_ef78ff05-8e0f-463a-88cd-ca9a01aed76a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pyridostigmine bromide oral
Dosage form: SOLUTION
Route: ORAL
Labeler: Novitium Pharma LLC
Application: ANDA211694
Marketing category: ANDA
Marketing start: 2019-03-11
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
A211694-001	PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA		2019-03-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211694-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211694-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2019-03-08	`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	A211694-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211694-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211694-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211694-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211694-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211694-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211694-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211694-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211694-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211694-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211694-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211694-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211694-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211694-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211694-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211694-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211694-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211694-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211694-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211694-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211694-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211694-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211694-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211694-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211694-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211694-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211694-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211694-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211694-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211694-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211694-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211694-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211694-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211694-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211694-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211694-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211694-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211694-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211694-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211694-001	AA	1	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A211694-001	CGT	2019-09-04	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A211694-001	CGT	2019-09-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211694-001	CGT	2019-09-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211694-001	CGT	2019-09-04	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Pyridostigmine
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 · 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
ef78ff05-8e0f-463a-88cd-ca9a01aed76a	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
70954-148-10	Pyridostigmine	473 mL in 1 BOTTLE	SOLUTION	473		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70954-148-10	ML - Milliliter	70954-148	6f5d15d6-d6ef-40b1-bb45-df3014f198cb	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70954-148	PYRIDOSTIGMINE (PYRIDOSTIGMINE BROMIDE ORAL) SOLUTION [NOVITIUM PHARMA LLC]	1	Current NDC, Legacy NDC, 1 package rows	20190321_ef78ff05-8e0f-463a-88cd-ca9a01aed76a.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	VistaPharm, LLC	9ab2ece0-7c0d-4045-a9f1-447aa97d623e	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211694 application number: ANDA211694
Pyridostigmine	PYRIDOSTIGMINE BROMIDE ORAL	Novitium Pharma LLC	ef78ff05-8e0f-463a-88cd-ca9a01aed76a	2019-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211694 application number: ANDA211694 ndc (product): 70954-148

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	9ab2ece0-7c0d-4045-a9f1-447aa97d623e	6
903843	pyridostigmine bromide 12 MG/ML Oral Solution	SCD	9ab2ece0-7c0d-4045-a9f1-447aa97d623e	6
903843	pyridostigmine bromide 60 MG per 5 ML Oral Solution	SY	9ab2ece0-7c0d-4045-a9f1-447aa97d623e	6
903843	pyRIDostigmine bromide 60 MG in 5 mL Oral Solution	PSN	ef78ff05-8e0f-463a-88cd-ca9a01aed76a	1
903843	pyridostigmine bromide 12 MG/ML Oral Solution	SCD	ef78ff05-8e0f-463a-88cd-ca9a01aed76a	1
903843	pyridostigmine bromide 60 MG per 5 ML Oral Solution	SY	ef78ff05-8e0f-463a-88cd-ca9a01aed76a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70954-148-10	70954014810	473 mL in 1 BOTTLE (70954-148-10)	473 ml	2019-03-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL VistaPharm, Inc.	VistaPharm, LLC	2025-11-25	HUMAN PRESCRIPTION DRUG LABEL	6
Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL.	Novitium Pharma LLC	2019-03-11	Human Prescription Drug Label	1