Pyridostigmine Bromide

Product NDC: 72458-128
11-digit product format: 724580128
Labeler code: 72458
Product ID: 72458-128_96f61532-26f7-4143-80f4-e62133499d21
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pyridostigmine Bromide
Dosage form: TABLET
Route: ORAL
Labeler: Surgeon General-Department of the Army (TSG-DA)
Application: NDA020414
Marketing category: NDA
Marketing start: 1990-12-05
Substance: PYRIDOSTIGMINE BROMIDE
Active strength: 30 mg/1
Pharmacologic classes: Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
N020414-001	PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL			2003-02-05

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020414-001	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	2003-02-05	`cb3db0bc1861…`

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	30 mg/1

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
903841	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
0b296555-c32f-42db-b5f3-ea981a3dd2f8	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
72458-128-02	2024-01-18	These highlights do not include all the information needed to use PYRIDOSTIGMINE BROMIDE TABLETS safely and effectively. See full prescribing information for PYRIDOSTIGMINE BROMIDE TABLETS . PYRIDOSTIGMINE BROMIDE tablets, for oral use Initial U.S. Approval: 1955
72458-128-04	2024-01-18	These highlights do not include all the information needed to use PYRIDOSTIGMINE BROMIDE TABLETS safely and effectively. See full prescribing information for PYRIDOSTIGMINE BROMIDE TABLETS . PYRIDOSTIGMINE BROMIDE tablets, for oral use Initial U.S. Approval: 1955
72458-128-02	2023-01-30	These highlights do not include all the information needed to use PYRIDOSTIGMINE BROMIDE TABLETS safely and effectively. See full prescribing information for PYRIDOSTIGMINE BROMIDE TABLETS . PYRIDOSTIGMINE BROMIDE tablets, for oral use Initial U.S. Approval: 1955
72458-128-04	2023-01-30	These highlights do not include all the information needed to use PYRIDOSTIGMINE BROMIDE TABLETS safely and effectively. See full prescribing information for PYRIDOSTIGMINE BROMIDE TABLETS . PYRIDOSTIGMINE BROMIDE tablets, for oral use Initial U.S. Approval: 1955

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72458-128-01	Pyridostigmine Bromide	21 in 1 BLISTER PACK	TABLET	21	6
72458-128-02	Pyridostigmine Bromide	10 in 1 BAG	TABLET	10	6
72458-128-03	Pyridostigmine Bromide	21 in 1 BLISTER PACK	TABLET	21	6
72458-128-04	Pyridostigmine Bromide	10 in 1 BAG	TABLET	10	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72458-128	PYRIDOSTIGMINE BROMIDE TABLET [SURGEON GENERAL-DEPARTMENT OF THE ARMY (TSG-DA)]	5	Current NDC, Legacy NDC, 4 package rows	20241025_0b296555-c32f-42db-b5f3-ea981a3dd2f8.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	Surgeon General-Department of the Army (TSG-DA)	0b296555-c32f-42db-b5f3-ea981a3dd2f8	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020414 application number: NDA020414 ndc (product): 72458-128

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
903841	pyRIDostigmine bromide 30 MG Oral Tablet	PSN	0b296555-c32f-42db-b5f3-ea981a3dd2f8	6
903841	pyridostigmine bromide 30 MG Oral Tablet	SCD	0b296555-c32f-42db-b5f3-ea981a3dd2f8	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72458-128-01	72458012801	21 in 1 BLISTER PACK						Historical
72458-128-02	72458012802	10 BLISTER PACK in 1 BAG (72458-128-02) / 21 TABLET in 1 BLISTER PACK (72458-128-01)	10 blister pack	1990-12-05	0000-00-00	No	No	Current
72458-128-03	72458012803	21 in 1 BLISTER PACK						Historical
72458-128-04	72458012804	10 BLISTER PACK in 1 BAG (72458-128-04) / 21 TABLET in 1 BLISTER PACK (72458-128-03)	10 blister pack	2017-07-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pyridostigmine Bromide	Surgeon General-Department of the Army (TSG-DA) \| Bausch Health Companies Inc.	2025-12-23	HUMAN PRESCRIPTION DRUG LABEL	6