Pryidostigmine Bromide

Product NDC: 73152-028
11-digit product format: 731520028
Labeler code: 73152
Product ID: 73152-028_bc2f5713-a002-893f-e053-2a95a90a770e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pyridostigmine Bromide
Dosage form: SOLUTION
Route: ORAL
Labeler: Athem LLC
Application: ANDA208797
Marketing category: ANDA
Marketing start: 2021-02-25
Marketing end: 0000-00-00
Substance: PYRIDOSTIGMINE BROMIDE
Active strength: 60 mg/5mL
Pharmacologic classes: Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	73152-028		I	Inactivated by FDA		2026-08-11
excluded package	package	73152-028	73152-028-16	I	Inactivated by FDA		2026-08-11

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
A208797-001	PYRIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA		2020-01-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208797-001	AA

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.

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	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208797-001	PYRIDOSTIGMINE BROMIDE	60MG/5ML	SYRUP / ORAL	AA	2020-01-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208797-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208797-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208797-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208797-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208797-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208797-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208797-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208797-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208797-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208797-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208797-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208797-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208797-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208797-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208797-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208797-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208797-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208797-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208797-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208797-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208797-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208797-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208797-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208797-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208797-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208797-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208797-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208797-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208797-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208797-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208797-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208797-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208797-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208797-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208797-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208797-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208797-001	AA	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cd6f4a37-8abf-2ed8-817f-5becdfa53ca5	Product name	9	20230112
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
dd640b44-88ec-4cbe-02c0-23127b95f5d3	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73152-028-16	2023-03-23	C162847	48780-1	f386c64a-024c-0266-e053-dadaa90a7c1a	Pyridostigmine Bromide Oral Solution USP
73152-028-16	2023-01-30	C162847	48780-1	f386c64a-024c-0266-e053-dadaa90a7c1a	Pyridostigmine Bromide Oral Solution USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73152-028-16	Pryidostigmine Bromide	473 mL in 1 BOTTLE, PLASTIC	SOLUTION	473		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73152-028	PRYIDOSTIGMINE BROMIDE (PYRIDOSTIGMINE BROMIDE) SOLUTION [ATHEM LLC]	4	Legacy NDC, 1 package rows	20230324_0d642561-8ade-460b-b6b0-78cfc6cc2694.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRYIDOSTIGMINE BROMIDE	PYRIDOSTIGMINE BROMIDE	Apnar Pharma LP	d42f2d2e-b9f8-7c22-e053-2995a90a9661	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208797 application number: ANDA208797
Pryidostigmine Bromide	PYRIDOSTIGMINE BROMIDE	Rising Pharma Holdings, Inc.	beda905e-005a-439d-ac74-92db4e269780	2022-09-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208797 application number: ANDA208797

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
903843	pyRIDostigmine bromide 60 MG in 5 mL Oral Solution	PSN	0d642561-8ade-460b-b6b0-78cfc6cc2694	4
903843	pyridostigmine bromide 12 MG/ML Oral Solution	SCD	0d642561-8ade-460b-b6b0-78cfc6cc2694	4
903843	pyridostigmine bromide 60 MG per 5 ML Oral Solution	SY	0d642561-8ade-460b-b6b0-78cfc6cc2694	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73152-028-16	73152002816	473 mL in 1 BOTTLE, PLASTIC (73152-028-16)	473 ml	2021-02-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pyridostigmine Bromide Oral Solution USP	Athem LLC \| InvaTech Pharma Solutions LLC	2023-03-23	HUMAN PRESCRIPTION DRUG LABEL	4