Pilocarpine Hydrochloride

Product NDC
17478-224
11-digit product format
174780224
Labeler code
17478
Product ID
17478-224_7353e797-47bb-45a4-8cbd-d99b357a4ea1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pilocarpine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
ANDA204398
Marketing category
ANDA
Marketing start
2017-09-28
Marketing end
0000-00-00
Substance
PILOCARPINE HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct17478-224IInactivated by FDA2026-08-03
excluded packagepackage17478-22417478-224-12IInactivated 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 · 30 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 packagepackage17478-224-12d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17478-224-12f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17478-224-122ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17478-224-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17478-224-12cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17478-224-12cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17478-224-12302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17478-224-12ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17478-224-120efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17478-224-12ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17478-224-12367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17478-224-12557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage17478-224-128af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage17478-224-12834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17478-224-121332a3947898…d4bfe170f9cd…

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
A204398-001PILOCARPINE HYDROCHLORIDEPILOCARPINE HYDROCHLORIDE1%SOLUTION/DROPS / OPHTHALMICAT2017-09-27
A204398-002PILOCARPINE HYDROCHLORIDEPILOCARPINE HYDROCHLORIDE2%SOLUTION/DROPS / OPHTHALMICAT2017-09-27
A204398-003PILOCARPINE HYDROCHLORIDEPILOCARPINE HYDROCHLORIDE4%SOLUTION/DROPS / OPHTHALMICAT2017-09-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204398-001AT
A204398-002AT
A204398-003AT

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204398-001PILOCARPINE HYDROCHLORIDE1%SOLUTION/DROPS / OPHTHALMICAT2017-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204398-002PILOCARPINE HYDROCHLORIDE2%SOLUTION/DROPS / OPHTHALMICAT2017-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204398-003PILOCARPINE HYDROCHLORIDE4%SOLUTION/DROPS / OPHTHALMICAT2017-09-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204398-001PILOCARPINE HYDROCHLORIDE1%SOLUTION/DROPS / OPHTHALMICAT2017-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204398-002PILOCARPINE HYDROCHLORIDE2%SOLUTION/DROPS / OPHTHALMICAT2017-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204398-003PILOCARPINE HYDROCHLORIDE4%SOLUTION/DROPS / OPHTHALMICAT2017-09-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A204398-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2017-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204398-002PILOCARPINE HYDROCHLORIDE2%SOLUTION / OPHTHALMICAT2017-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204398-003PILOCARPINE HYDROCHLORIDE4%SOLUTION / OPHTHALMICAT2017-09-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204398-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2017-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204398-002PILOCARPINE HYDROCHLORIDE2%SOLUTION / OPHTHALMICAT2017-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204398-003PILOCARPINE HYDROCHLORIDE4%SOLUTION / OPHTHALMICAT2017-09-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204398-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2017-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204398-002PILOCARPINE HYDROCHLORIDE2%SOLUTION / OPHTHALMICAT2017-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204398-003PILOCARPINE HYDROCHLORIDE4%SOLUTION / OPHTHALMICAT2017-09-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204398-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2017-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204398-002PILOCARPINE HYDROCHLORIDE2%SOLUTION / OPHTHALMICAT2017-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204398-003PILOCARPINE HYDROCHLORIDE4%SOLUTION / OPHTHALMICAT2017-09-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204398-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2017-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204398-002PILOCARPINE HYDROCHLORIDE2%SOLUTION / OPHTHALMICAT2017-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204398-003PILOCARPINE HYDROCHLORIDE4%SOLUTION / OPHTHALMICAT2017-09-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204398-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2017-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204398-002PILOCARPINE HYDROCHLORIDE2%SOLUTION / OPHTHALMICAT2017-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204398-003PILOCARPINE HYDROCHLORIDE4%SOLUTION / OPHTHALMICAT2017-09-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204398-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2017-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204398-002PILOCARPINE HYDROCHLORIDE2%SOLUTION / OPHTHALMICAT2017-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204398-003PILOCARPINE HYDROCHLORIDE4%SOLUTION / OPHTHALMICAT2017-09-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204398-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2017-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A204398-002PILOCARPINE HYDROCHLORIDE2%SOLUTION / OPHTHALMICAT2017-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A204398-003PILOCARPINE HYDROCHLORIDE4%SOLUTION / OPHTHALMICAT2017-09-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204398-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2017-09-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204398-002PILOCARPINE HYDROCHLORIDE2%SOLUTION / OPHTHALMICAT2017-09-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204398-003PILOCARPINE HYDROCHLORIDE4%SOLUTION / OPHTHALMICAT2017-09-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204398-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2017-09-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204398-002PILOCARPINE HYDROCHLORIDE2%SOLUTION / OPHTHALMICAT2017-09-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204398-003PILOCARPINE HYDROCHLORIDE4%SOLUTION / OPHTHALMICAT2017-09-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204398-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2017-09-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204398-002PILOCARPINE HYDROCHLORIDE2%SOLUTION / OPHTHALMICAT2017-09-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204398-003PILOCARPINE HYDROCHLORIDE4%SOLUTION / OPHTHALMICAT2017-09-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204398-001PILOCARPINE HYDROCHLORIDE1%SOLUTION / OPHTHALMICAT2017-09-278072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204398-001AT1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204398-002AT1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204398-003AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204398-001AT131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204398-002AT131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204398-003AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204398-001AT16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204398-002AT16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204398-003AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204398-001AT1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204398-002AT1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204398-003AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204398-001AT1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204398-002AT1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204398-003AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204398-001AT103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204398-002AT103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204398-003AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204398-001AT12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204398-002AT12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204398-003AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204398-001AT15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204398-002AT15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204398-003AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204398-001AT1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204398-002AT1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204398-003AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204398-001AT1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204398-002AT1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204398-003AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204398-001AT179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204398-002AT179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204398-003AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204398-001AT1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204398-002AT1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204398-003AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204398-001AT11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204398-002AT11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204398-003AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204398-001AT18072bd15b7f6…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-224-12Pilocarpine Hydrochloride15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS157
17478-224-12Pilocarpine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-224-12ML - Milliliter17478-2240533f1ec-cb0c-4b7b-8043-405b1a81e58812012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-224PILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [AKORN]7Legacy NDC, 2 package rows20220710_fa03947c-6844-45df-aa22-b584c5681269.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000647pilocarpine HCl 1 % Ophthalmic SolutionPSNfa03947c-6844-45df-aa22-b584c56812697
1000862pilocarpine HCl 2 % Ophthalmic SolutionPSNfa03947c-6844-45df-aa22-b584c56812697
1000897pilocarpine HCl 4 % Ophthalmic SolutionPSNfa03947c-6844-45df-aa22-b584c56812697
1000647pilocarpine hydrochloride 10 MG/ML Ophthalmic SolutionSCDfa03947c-6844-45df-aa22-b584c56812697
1000862pilocarpine hydrochloride 20 MG/ML Ophthalmic SolutionSCDfa03947c-6844-45df-aa22-b584c56812697
1000897pilocarpine hydrochloride 40 MG/ML Ophthalmic SolutionSCDfa03947c-6844-45df-aa22-b584c56812697
1000647pilocarpine hydrochloride 1 % Ophthalmic SolutionSYfa03947c-6844-45df-aa22-b584c56812697
1000862pilocarpine hydrochloride 2 % Ophthalmic SolutionSYfa03947c-6844-45df-aa22-b584c56812697
1000897pilocarpine hydrochloride 4 % Ophthalmic SolutionSYfa03947c-6844-45df-aa22-b584c56812697

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17478-224-12174780224121 BOTTLE, DROPPER in 1 CARTON (17478-224-12) > 15 mL in 1 BOTTLE, DROPPER2017-09-280000-00-00NoNoCurrent