FDA.reportPublic FDA data

Pilocarpine Hydrochloride Ophthalmic

Product NDC
60219-2649
11-digit product format
602192649
Labeler code
60219
Product ID
60219-2649_a804f045-c81b-469d-848d-475bf8aac237
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pilocarpine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA217733
Marketing category
ANDA
Marketing start
2025-09-01
Substance
PILOCARPINE HYDROCHLORIDE
Active strength
12.5 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217733-001PILOCARPINE HYDROCHLORIDEPILOCARPINE HYDROCHLORIDE1.25%SOLUTION/DROPS / OPHTHALMICRS2025-04-28

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217733-001PILOCARPINE HYDROCHLORIDE1.25%SOLUTION/DROPS / OPHTHALMICAB2025-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217733-001PILOCARPINE HYDROCHLORIDE1.25%SOLUTION/DROPS / OPHTHALMICAB2025-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A217733-001PILOCARPINE HYDROCHLORIDE1.25%SOLUTION / OPHTHALMICAB2025-04-286a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217733-001PILOCARPINE HYDROCHLORIDE1.25%SOLUTION/DROPS / OPHTHALMICRS2025-04-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217733-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217733-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217733-001AB16a471c1ec25d…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PILOCARPINE HYDROCHLORIDE12.5 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2584552Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
93e37b61-7b90-4740-b0b4-17d39d3b03f6Available 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
dad00d81-2cbe-bbab-dd06-a12043b5e56dProduct name420210512
419b812f-d1a6-2de2-5dee-bec68d6ec699Product name220200123
38c480e0-b6d3-b416-6514-a787406e5176Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60219-2649-1Pilocarpine Hydrochloride Ophthalmic5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS56
60219-2649-1Pilocarpine Hydrochloride Ophthalmic1 in 1 CARTONSOLUTION/ DROPS16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-2649-1ML - Milliliter60219-26496c440c89-a7ab-4a11-b75c-46f99517c29212025-10-14

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 Hydrochloride OphthalmicPILOCARPINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLC93e37b61-7b90-4740-b0b4-17d39d3b03f62025-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217733
application number: ANDA217733
ndc (product): 60219-2649

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2584552pilocarpine HCl 1.25 % Ophthalmic SolutionPSN93e37b61-7b90-4740-b0b4-17d39d3b03f66
2584552pilocarpine hydrochloride 12.5 MG/ML Ophthalmic SolutionSCD93e37b61-7b90-4740-b0b4-17d39d3b03f66
2584552pilocarpine hydrochloride 1.25 % Ophthalmic SolutionSY93e37b61-7b90-4740-b0b4-17d39d3b03f66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60219-2649-1602192649011 BOTTLE, DROPPER in 1 CARTON (60219-2649-1) / 5 mL in 1 BOTTLE, DROPPER2025-09-01NoNoCurrent