Pyridostigmine Bromide

Product NDC: 0115-3511
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

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
PYRIDOSTIGMINE BROMIDE	60 mg/1

Field, Values table
Field	Values
Unii	KVI301NA53
Rxcui	903857

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

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

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

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

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

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

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

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0115-3511-01	00115351101	100 TABLET in 1 BOTTLE (0115-3511-01)	100 tablet	2003-04-24	0000-00-00	No	No	Current
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