Pyridostigmine Bromide

Product NDC: 64980-220
11-digit product format: 649800220
Labeler code: 64980
Product ID: 64980-220_34812796-3684-4619-a70c-fc93e22d123a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pyridostigmine Bromide
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA205464
Marketing category: ANDA
Marketing start: 2017-08-15
Substance: PYRIDOSTIGMINE BROMIDE
Active strength: 180 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205464-001	PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205464-001	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 · 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	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205464-001	PYRIDOSTIGMINE BROMIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-08-15	`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	A205464-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205464-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205464-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205464-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205464-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205464-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205464-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205464-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205464-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205464-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205464-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205464-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205464-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205464-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205464-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205464-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205464-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205464-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205464-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205464-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205464-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205464-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205464-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205464-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205464-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205464-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205464-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205464-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205464-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205464-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205464-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205464-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205464-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205464-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205464-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205464-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205464-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205464-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205464-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205464-001	AB	1	`cb3db0bc1861…`

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	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
f7a75639-a23a-4847-a962-c091c61947f0	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
64980-220-03	Pyridostigmine Bromide	30 in 1 BOTTLE	TABLET	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64980-220-03	EA - Each	64980-220	48c7031f-43e6-4101-9ad9-621975ac0a52	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64980-220	PYRIDOSTIGMINE BROMIDE TABLET [RISING PHARMACEUTICALS, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20221108_f7a75639-a23a-4847-a962-c091c61947f0.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	Rising Pharma Holdings, Inc.	f7a75639-a23a-4847-a962-c091c61947f0	2025-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205464 application number: ANDA205464 ndc (product): 64980-220

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	f7a75639-a23a-4847-a962-c091c61947f0	4
903847	pyridostigmine bromide 180 MG Extended Release Oral Tablet	SCD	f7a75639-a23a-4847-a962-c091c61947f0	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64980-220-03	64980022003	30 TABLET in 1 BOTTLE (64980-220-03)	30 tablet	2017-08-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pyridostigmine Bromide Extended-Release Tablets, 180 mg	Rising Pharma Holdings, Inc. \| Centaur Pharmaceuticals Private Limited	2025-06-11	Human Prescription Drug Label	4