Pilocarpine Hydrochloride

Product NDC
10135-680
11-digit product format
101350680
Labeler code
10135
Product ID
10135-680_ab361398-0213-4453-a29e-2f6215e3a7cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pilocarpine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA076963
Marketing category
ANDA
Marketing start
2019-02-01
Marketing end
0000-00-00
Substance
PILOCARPINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10135-680IInactivated by FDA2026-08-03
excluded packagepackage10135-68010135-680-01IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 38 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10135-680-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10135-680-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10135-680-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10135-680-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10135-680-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10135-680-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10135-680-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10135-680-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10135-680-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10135-680-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10135-680-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10135-680-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10135-680-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10135-680-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10135-680-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage10135-680-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage10135-680-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage10135-680-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage10135-680-018dfbde2a14a4…c9ff85d89658…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076963-001PILOCARPINE HYDROCHLORIDEPILOCARPINE HYDROCHLORIDE5MGTABLET / ORALAB2004-12-22
A076963-002PILOCARPINE HYDROCHLORIDEPILOCARPINE HYDROCHLORIDE7.5MGTABLET / ORALAB2007-02-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A076963-001AB
A076963-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076963-001PILOCARPINE HYDROCHLORIDE5MGTABLET / ORALAB2004-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076963-002PILOCARPINE HYDROCHLORIDE7.5MGTABLET / ORALAB2007-02-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076963-001PILOCARPINE HYDROCHLORIDE5MGTABLET / ORALAB2004-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076963-002PILOCARPINE HYDROCHLORIDE7.5MGTABLET / ORALAB2007-02-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A076963-001PILOCARPINE HYDROCHLORIDE5MGTABLET / ORALAB2004-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076963-002PILOCARPINE HYDROCHLORIDE7.5MGTABLET / ORALAB2007-02-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076963-001PILOCARPINE HYDROCHLORIDE5MGTABLET / ORALAB2004-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076963-002PILOCARPINE HYDROCHLORIDE7.5MGTABLET / ORALAB2007-02-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076963-001PILOCARPINE HYDROCHLORIDE5MGTABLET / ORALAB2004-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076963-002PILOCARPINE HYDROCHLORIDE7.5MGTABLET / ORALAB2007-02-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076963-001PILOCARPINE HYDROCHLORIDE5MGTABLET / ORALAB2004-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076963-002PILOCARPINE HYDROCHLORIDE7.5MGTABLET / ORALAB2007-02-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076963-001PILOCARPINE HYDROCHLORIDE5MGTABLET / ORALAB2004-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076963-002PILOCARPINE HYDROCHLORIDE7.5MGTABLET / ORALAB2007-02-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076963-001PILOCARPINE HYDROCHLORIDE5MGTABLET / ORALAB2004-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076963-002PILOCARPINE HYDROCHLORIDE7.5MGTABLET / ORALAB2007-02-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076963-001PILOCARPINE HYDROCHLORIDE5MGTABLET / ORALAB2004-12-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076963-002PILOCARPINE HYDROCHLORIDE7.5MGTABLET / ORALAB2007-02-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076963-001PILOCARPINE HYDROCHLORIDE5MGTABLET / ORALAB2004-12-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A076963-002PILOCARPINE HYDROCHLORIDE7.5MGTABLET / ORALAB2007-02-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076963-001PILOCARPINE HYDROCHLORIDE5MGTABLET / ORALAB2004-12-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076963-002PILOCARPINE HYDROCHLORIDE7.5MGTABLET / ORALAB2007-02-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076963-001PILOCARPINE HYDROCHLORIDE5MGTABLET / ORALAB2004-12-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076963-002PILOCARPINE HYDROCHLORIDE7.5MGTABLET / ORALAB2007-02-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076963-001PILOCARPINE HYDROCHLORIDE5MGTABLET / ORALAB2004-12-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076963-002PILOCARPINE HYDROCHLORIDE7.5MGTABLET / ORALAB2007-02-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076963-001PILOCARPINE HYDROCHLORIDE5MGTABLET / ORALAB2004-12-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076963-002PILOCARPINE HYDROCHLORIDE7.5MGTABLET / ORALAB2007-02-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076963-001PILOCARPINE HYDROCHLORIDE5MGTABLET / ORALAB2004-12-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076963-002PILOCARPINE HYDROCHLORIDE7.5MGTABLET / ORALAB2007-02-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076963-001PILOCARPINE HYDROCHLORIDE5MGTABLET / ORALAB2004-12-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076963-002PILOCARPINE HYDROCHLORIDE7.5MGTABLET / ORALAB2007-02-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076963-001PILOCARPINE HYDROCHLORIDE5MGTABLET / ORALAB2004-12-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076963-002PILOCARPINE HYDROCHLORIDE7.5MGTABLET / ORALAB2007-02-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076963-001PILOCARPINE HYDROCHLORIDE5MGTABLET / ORALAB2004-12-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076963-002PILOCARPINE HYDROCHLORIDE7.5MGTABLET / ORALAB2007-02-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076963-001PILOCARPINE HYDROCHLORIDE5MGTABLET / ORALAB2004-12-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076963-002PILOCARPINE HYDROCHLORIDE7.5MGTABLET / ORALAB2007-02-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076963-001PILOCARPINE HYDROCHLORIDE5MGTABLET / ORALAB2004-12-22782e0a99824c…
2021-12-28 21:50 UTC2021-12A076963-002PILOCARPINE HYDROCHLORIDE7.5MGTABLET / ORALAB2007-02-27782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076963-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076963-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076963-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076963-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076963-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076963-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076963-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076963-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076963-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076963-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076963-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076963-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076963-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076963-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076963-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076963-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076963-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076963-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076963-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076963-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076963-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076963-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076963-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076963-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076963-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076963-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076963-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076963-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076963-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076963-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076963-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076963-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076963-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076963-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076963-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076963-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076963-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076963-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076963-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A076963-002AB1782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
92fc48b4-3815-4611-a8be-f74b29f9b350Product name220260130
c8f45a17-34ae-46eb-871b-470615085910Product name120250630
dad00d81-2cbe-bbab-dd06-a12043b5e56dProduct name420210512
419b812f-d1a6-2de2-5dee-bec68d6ec699Product name220200123
38c480e0-b6d3-b416-6514-a787406e5176Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-680-012021-01-29C16284748780-1ba0f9c33-1a78-a910-e053-dadaa90a0b85Pilocarpine Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-680-01Pilocarpine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-680-01EA - Each10135-6809320387b-58a2-4bfd-b177-ef4b24a1ff9912019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-680PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]1Legacy NDC, 1 package rows20190227_4b856409-ee10-455b-a0f3-69c65df69123.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pilocarpine HydrochloridePILOCARPINE HYDROCHLORIDEAMICI PHARMACEUTICALS LLCa86a7b63-5f6a-4c10-9270-24c7b7d504372022-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076963
application number: ANDA076963

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000913pilocarpine HCl 5 MG Oral TabletPSN4b856409-ee10-455b-a0f3-69c65df691231
1000913pilocarpine hydrochloride 5 MG Oral TabletSCD4b856409-ee10-455b-a0f3-69c65df691231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-680-0110135068001100 in 1 BOTTLEHistorical