Pyridostigmine Bromide

Product NDC: 0115-3511
Requested package NDC: 0115-3511-02
11-digit product format: 001153511
Labeler code: 0115
Product ID: 0115-3511_3d2e45fb-a83b-4e76-b1cd-9caf2b00a804
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PYRIDOSTIGMINE BROMIDE
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA040502
Marketing category: ANDA
Marketing start: 2003-04-24
Substance: PYRIDOSTIGMINE BROMIDE
Active strength: 60 mg/1
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040502-001	PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB		2003-04-24
A040502-002	PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB		2022-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040502-001	AB
A040502-002	AB

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 · 69 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	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040502-002	PYRIDOSTIGMINE BROMIDE	30MG	TABLET / ORAL	AB	2022-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040502-001	PYRIDOSTIGMINE BROMIDE	60MG	TABLET / ORAL	AB	2003-04-24	`b00525d2431f…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 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	A040502-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040502-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040502-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040502-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040502-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040502-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040502-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040502-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040502-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040502-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040502-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040502-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040502-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040502-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040502-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040502-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040502-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040502-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040502-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040502-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040502-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040502-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040502-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040502-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040502-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040502-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040502-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040502-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040502-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040502-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040502-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040502-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040502-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040502-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040502-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040502-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040502-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040502-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040502-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040502-001	AB	1	`b00525d2431f…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PYRIDOSTIGMINE BROMIDE	60 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
903857	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
0f56facf-1f0a-4ba5-876d-757b114dfa45	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
0115-3511-01	Pyridostigmine Bromide	100 in 1 BOTTLE	TABLET	100		17
0115-3511-02	Pyridostigmine Bromide	500 in 1 BOTTLE	TABLET	500		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-3511-01	EA - Each	0115-3511	9c8b3043-ecdd-4733-a516-a1502b22d27a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PYRIDOSTIGMINE BROMIDE	ACTIVE INGREDIENT	KVI301NA53	PYRIDOSTIGMINE BROMIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	4
PYRIDOSTIGMINE	ACTIVE MOIETY	19QM69HH21	PYRIDOSTIGMINE BROMIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PYRIDOSTIGMINE BROMIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PYRIDOSTIGMINE BROMIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PYRIDOSTIGMINE BROMIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PYRIDOSTIGMINE BROMIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	4
PYRIDOSTIGMINE BROMIDE	ACTIVE INGREDIENT	KVI301NA53	PYRIDOSTIGMINE BROMIDE TABLET [AMERICAN HEALTH PACKAGING]	2
PYRIDOSTIGMINE	ACTIVE MOIETY	19QM69HH21	PYRIDOSTIGMINE BROMIDE TABLET [AMERICAN HEALTH PACKAGING]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PYRIDOSTIGMINE BROMIDE TABLET [AMERICAN HEALTH PACKAGING]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PYRIDOSTIGMINE BROMIDE TABLET [AMERICAN HEALTH PACKAGING]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PYRIDOSTIGMINE BROMIDE TABLET [AMERICAN HEALTH PACKAGING]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PYRIDOSTIGMINE BROMIDE TABLET [AMERICAN HEALTH PACKAGING]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0115-3511	PYRIDOSTIGMINE BROMIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	16	Current NDC, Legacy NDC, 2 package rows	20241211_0f56facf-1f0a-4ba5-876d-757b114dfa45.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Amneal Pharmaceuticals of New York LLC	0f56facf-1f0a-4ba5-876d-757b114dfa45	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040502 application number: ANDA040502 ndc (package): 0115-3511-02 ndc (product): 0115-3511 ndc11 (package): 00115351102
Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	American Health Packaging	30cb0b9f-e308-4501-90c2-b17349c048b7	2025-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040502 application number: ANDA040502
Pyridostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Amneal Pharmaceuticals of New York LLC	91ca7bcf-d2cc-4cb3-bfbe-c294fd707524	2023-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040502 application number: ANDA040502

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
903857	pyRIDostigmine bromide 60 MG Oral Tablet	PSN	0f56facf-1f0a-4ba5-876d-757b114dfa45	17
903857	pyridostigmine bromide 60 MG Oral Tablet	SCD	0f56facf-1f0a-4ba5-876d-757b114dfa45	17
903857	pyRIDostigmine bromide 60 MG Oral Tablet	PSN	30cb0b9f-e308-4501-90c2-b17349c048b7	11
903857	pyridostigmine bromide 60 MG Oral Tablet	SCD	30cb0b9f-e308-4501-90c2-b17349c048b7	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0115-3511-02	00115351102	500 TABLET in 1 BOTTLE (0115-3511-02)	500 tablet	2003-04-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pyridostigmine Bromide Tablets, USP (60 mg) Rx only	Amneal Pharmaceuticals of New York LLC \| Amneal Pharmaceuticals Private Limited	2025-10-16	HUMAN PRESCRIPTION DRUG LABEL	17
Pyridostigmine Bromide Tablets, USP 8249401/0125 Rx only	American Health Packaging	2025-06-25	HUMAN PRESCRIPTION DRUG LABEL	11