Pyridostigmine Bromide

Product NDC: 47781-335
11-digit product format: 477810335
Labeler code: 47781
Product ID: 47781-335_ab081740-9930-44ae-4080-1902069226f2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pyridostigmine Bromide
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Alvogen, Inc.
Application: ANDA204737
Marketing category: ANDA
Marketing start: 2015-06-29
Substance: PYRIDOSTIGMINE BROMIDE
Active strength: 180 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 45.

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
A204737-001	PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-06-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204737-001	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 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-11-14 07:37:17	2026-10	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-06-26	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-06-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-06-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204737-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-06-26	`3bdfa0b2c4d7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-11-14 07:37:17	2026-10	A204737-001	AB	1	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A204737-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204737-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204737-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204737-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204737-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204737-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204737-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204737-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204737-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204737-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204737-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204737-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204737-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204737-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204737-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204737-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204737-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204737-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204737-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204737-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204737-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204737-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204737-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204737-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204737-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204737-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204737-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204737-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204737-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204737-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204737-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204737-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204737-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204737-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204737-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204737-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204737-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204737-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204737-001	AB	1	`3bdfa0b2c4d7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	180 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
903847	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
93454159-0c58-1980-34b9-4038a2260420	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
47781-335-30	Pyridostigmine Bromide	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47781-335-30	EA - Each	47781-335	6faebc23-9a38-41d4-95c5-b56ac49636e0	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PYRIDOSTIGMINE BROMIDE	ACTIVE INGREDIENT	KVI301NA53	PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE [ALVOGEN INC.]	4
PYRIDOSTIGMINE	ACTIVE MOIETY	19QM69HH21	PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE [ALVOGEN INC.]	4
CALCIUM PHOSPHATE	INACTIVE INGREDIENT	97Z1WI3NDX	PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE [ALVOGEN INC.]	4
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE [ALVOGEN INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE [ALVOGEN INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE [ALVOGEN INC.]	4
ZEIN	INACTIVE INGREDIENT	80N308T1NN	PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE [ALVOGEN INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47781-335	PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE [ALVOGEN, INC.]	12	Current NDC, Legacy NDC, 1 package rows	20241012_93454159-0c58-1980-34b9-4038a2260420.zip

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
903847	pyRIDostigmine bromide 180 MG Extended Release Oral Tablet	PSN	93454159-0c58-1980-34b9-4038a2260420	14
903847	pyridostigmine bromide 180 MG Extended Release Oral Tablet	SCD	93454159-0c58-1980-34b9-4038a2260420	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
47781-335-30	47781033530	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-335-30)	2015-06-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pyridostigmine Bromide Extended-release Tablets, 180 mg Rx Only	Alvogen, Inc. \| Norwich Pharmaceuticals, Inc.	2025-10-09	HUMAN PRESCRIPTION DRUG LABEL	14