pyridostigmine bromide

Product NDC
51407-590
11-digit product format
514070590
Labeler code
51407
Product ID
51407-590_235c6f7c-50e0-3382-e063-6394a90ad761
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pyridostigmine bromide
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA205650
Marketing category
ANDA
Marketing start
2015-06-22
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205650-001PYRIDOSTIGMINE BROMIDEPYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205650-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-223f01610625f2…
2019-09-15 20:21 UTC2019-09A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205650-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2015-06-22cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A205650-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205650-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205650-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205650-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205650-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205650-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205650-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205650-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205650-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205650-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205650-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205650-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205650-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205650-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205650-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205650-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205650-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205650-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205650-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205650-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205650-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A205650-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205650-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205650-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205650-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A205650-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205650-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205650-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205650-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205650-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205650-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205650-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205650-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205650-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A205650-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A205650-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205650-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205650-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205650-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205650-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
pyridostigmine bromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRIDOSTIGMINE BROMIDE60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KVI301NA53Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
903857Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
235c6c04-3c09-0cf8-e063-6394a90a1846Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cd6f4a37-8abf-2ed8-817f-5becdfa53ca5Product name920230112
dd640b44-88ec-4cbe-02c0-23127b95f5d3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-590-30pyridostigmine bromide30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-590-30EA - Each51407-590b5bc7750-986b-479c-bc0e-ed905067b06712024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-590PYRIDOSTIGMINE BROMIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1Current NDC, 1 package rows20241004_235c6c04-3c09-0cf8-e063-6394a90a1846.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pyridostigmine bromidePYRIDOSTIGMINE BROMIDEMajor Pharmaceuticals36284496-e56e-466c-9b56-6007bb5bb6992025-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205650
application number: ANDA205650
pyridostigmine bromidePYRIDOSTIGMINE BROMIDEGolden State Medical Supply, Inc.235c6c04-3c09-0cf8-e063-6394a90a18462024-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205650
application number: ANDA205650
ndc (product): 51407-590
pyridostigmine bromidePYRIDOSTIGMINE BROMIDEZydus Lifesciences Limitedea4f753f-41a0-4f82-932c-181883d4b6d32023-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205650
application number: ANDA205650
pyridostigmine bromidePYRIDOSTIGMINE BROMIDEZydus Pharmaceuticals (USA) Inc.44e8c2dd-3931-4508-9fa7-5a660d6dfddb2023-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205650
application number: ANDA205650

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903857pyRIDostigmine bromide 60 MG Oral TabletPSN235c6c04-3c09-0cf8-e063-6394a90a18461
903857pyridostigmine bromide 60 MG Oral TabletSCD235c6c04-3c09-0cf8-e063-6394a90a18461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-590-305140705903030 TABLET in 1 BOTTLE (51407-590-30) 30 tablet2024-09-25NoNoCurrent