FDA.reportPublic FDA data

Pilocarpine Hydrochloride

Product NDC
69238-1747
11-digit product format
692381747
Labeler code
69238
Product ID
69238-1747_9741ba5e-b7e7-4842-9982-58ccdd11919e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pilocarpine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA214193
Marketing category
ANDA
Marketing start
2020-09-23
Substance
PILOCARPINE HYDROCHLORIDE
Active strength
40 mg/mL
Pharmacologic classes
Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214193-001PILOCARPINE HYDROCHLORIDEPILOCARPINE HYDROCHLORIDE1%SOLUTION/DROPS / OPHTHALMICAT2020-09-21
A214193-002PILOCARPINE HYDROCHLORIDEPILOCARPINE HYDROCHLORIDE2%SOLUTION/DROPS / OPHTHALMICAT2020-09-21
A214193-003PILOCARPINE HYDROCHLORIDEPILOCARPINE HYDROCHLORIDE4%SOLUTION/DROPS / OPHTHALMICAT2020-09-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A214193-001AT
A214193-002AT
A214193-003AT

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 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214193-001PILOCARPINE HYDROCHLORIDE1%SOLUTION/DROPS / OPHTHALMICAT2020-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214193-002PILOCARPINE HYDROCHLORIDE2%SOLUTION/DROPS / OPHTHALMICAT2020-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214193-003PILOCARPINE HYDROCHLORIDE4%SOLUTION/DROPS / OPHTHALMICAT2020-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214193-001PILOCARPINE HYDROCHLORIDE1%SOLUTION/DROPS / OPHTHALMICAT2020-09-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214193-002PILOCARPINE HYDROCHLORIDE2%SOLUTION/DROPS / OPHTHALMICAT2020-09-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214193-003PILOCARPINE HYDROCHLORIDE4%SOLUTION/DROPS / OPHTHALMICAT2020-09-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214193-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2020-09-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214193-002PILOCARPINE HYDROCHLORIDE2%SOLUTION / OPHTHALMICAT2020-09-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214193-003PILOCARPINE HYDROCHLORIDE4%SOLUTION / OPHTHALMICAT2020-09-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214193-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2020-09-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214193-002PILOCARPINE HYDROCHLORIDE2%SOLUTION / OPHTHALMICAT2020-09-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214193-003PILOCARPINE HYDROCHLORIDE4%SOLUTION / OPHTHALMICAT2020-09-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214193-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2020-09-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214193-002PILOCARPINE HYDROCHLORIDE2%SOLUTION / OPHTHALMICAT2020-09-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214193-003PILOCARPINE HYDROCHLORIDE4%SOLUTION / OPHTHALMICAT2020-09-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214193-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2020-09-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214193-002PILOCARPINE HYDROCHLORIDE2%SOLUTION / OPHTHALMICAT2020-09-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214193-003PILOCARPINE HYDROCHLORIDE4%SOLUTION / OPHTHALMICAT2020-09-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214193-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2020-09-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214193-002PILOCARPINE HYDROCHLORIDE2%SOLUTION / OPHTHALMICAT2020-09-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214193-003PILOCARPINE HYDROCHLORIDE4%SOLUTION / OPHTHALMICAT2020-09-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214193-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2020-09-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214193-002PILOCARPINE HYDROCHLORIDE2%SOLUTION / OPHTHALMICAT2020-09-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214193-003PILOCARPINE HYDROCHLORIDE4%SOLUTION / OPHTHALMICAT2020-09-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214193-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2020-09-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214193-002PILOCARPINE HYDROCHLORIDE2%SOLUTION / OPHTHALMICAT2020-09-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214193-003PILOCARPINE HYDROCHLORIDE4%SOLUTION / OPHTHALMICAT2020-09-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214193-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2020-09-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A214193-002PILOCARPINE HYDROCHLORIDE2%SOLUTION / OPHTHALMICAT2020-09-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A214193-003PILOCARPINE HYDROCHLORIDE4%SOLUTION / OPHTHALMICAT2020-09-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214193-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2020-09-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214193-002PILOCARPINE HYDROCHLORIDE2%SOLUTION / OPHTHALMICAT2020-09-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214193-003PILOCARPINE HYDROCHLORIDE4%SOLUTION / OPHTHALMICAT2020-09-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214193-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2020-09-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214193-002PILOCARPINE HYDROCHLORIDE2%SOLUTION / OPHTHALMICAT2020-09-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214193-003PILOCARPINE HYDROCHLORIDE4%SOLUTION / OPHTHALMICAT2020-09-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214193-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2020-09-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214193-002PILOCARPINE HYDROCHLORIDE2%SOLUTION / OPHTHALMICAT2020-09-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214193-003PILOCARPINE HYDROCHLORIDE4%SOLUTION / OPHTHALMICAT2020-09-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214193-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2020-09-218072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214193-001AT1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214193-002AT1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214193-003AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214193-001AT131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214193-002AT131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214193-003AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214193-001AT16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214193-002AT16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214193-003AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214193-001AT1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214193-002AT1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214193-003AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214193-001AT1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214193-002AT1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214193-003AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214193-001AT103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214193-002AT103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214193-003AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214193-001AT12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214193-002AT12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214193-003AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214193-001AT15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214193-002AT15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214193-003AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214193-001AT1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214193-002AT1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214193-003AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214193-001AT1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214193-002AT1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214193-003AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214193-001AT179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214193-002AT179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214193-003AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214193-001AT1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214193-002AT1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214193-003AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214193-001AT11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214193-002AT11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214193-003AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214193-001AT18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Pilocarpine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PILOCARPINE HYDROCHLORIDE40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0WW6D218XJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000647Internal RxNorm lookup
1000862Internal RxNorm lookup
1000897Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1e87a81a-7084-4436-918b-a50451534307Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
92fc48b4-3815-4611-a8be-f74b29f9b350Product name220260130
c8f45a17-34ae-46eb-871b-470615085910Product name120250630
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
dad00d81-2cbe-bbab-dd06-a12043b5e56dProduct name420210512
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
419b812f-d1a6-2de2-5dee-bec68d6ec699Product name220200123
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
38c480e0-b6d3-b416-6514-a787406e5176Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1747-8Pilocarpine Hydrochloride15 mL in 1 BOTTLESOLUTION/ DROPS1512
69238-1747-8Pilocarpine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1747-8ML - Milliliter69238-1747a9906425-c6db-428c-a170-c982a22ac96012021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1747PILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [AMNEAL PHARMACEUTICALS NY LLC]12Current NDC, Legacy NDC, 2 package rows20240806_1e87a81a-7084-4436-918b-a50451534307.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 HYDROCHLORIDEAmneal Pharmaceuticals NY LLC1e87a81a-7084-4436-918b-a504515343072021-01-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214193
application number: ANDA214193
ndc (product): 69238-1747

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000647pilocarpine HCl 1 % Ophthalmic SolutionPSN1e87a81a-7084-4436-918b-a5045153430712
1000862pilocarpine HCl 2 % Ophthalmic SolutionPSN1e87a81a-7084-4436-918b-a5045153430712
1000897pilocarpine HCl 4 % Ophthalmic SolutionPSN1e87a81a-7084-4436-918b-a5045153430712
1000647pilocarpine hydrochloride 10 MG/ML Ophthalmic SolutionSCD1e87a81a-7084-4436-918b-a5045153430712
1000862pilocarpine hydrochloride 20 MG/ML Ophthalmic SolutionSCD1e87a81a-7084-4436-918b-a5045153430712
1000897pilocarpine hydrochloride 40 MG/ML Ophthalmic SolutionSCD1e87a81a-7084-4436-918b-a5045153430712
1000647pilocarpine hydrochloride 1 % Ophthalmic SolutionSY1e87a81a-7084-4436-918b-a5045153430712
1000862pilocarpine hydrochloride 2 % Ophthalmic SolutionSY1e87a81a-7084-4436-918b-a5045153430712
1000897pilocarpine hydrochloride 4 % Ophthalmic SolutionSY1e87a81a-7084-4436-918b-a5045153430712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1747-8692381747081 BOTTLE in 1 CARTON (69238-1747-8) / 15 mL in 1 BOTTLE1 bottle2020-09-230000-00-00NoNoCurrent