Home NDC 61314-203 Pilocarpine Hydrochloride
Product NDC 61314-203
11-digit product format 613140203
Labeler code 61314
Product ID 61314-203_305559df-eb9c-4584-b5c5-0a83505b4bb0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pilocarpine hydrochloride
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Sandoz Inc
Application NDA200890
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2011-09-30
Substance PILOCARPINE HYDROCHLORIDE
Active strength 10 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N200890-001 ISOPTO CARPINE PILOCARPINE HYDROCHLORIDE 1% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-06-22 N200890-002 ISOPTO CARPINE PILOCARPINE HYDROCHLORIDE 2% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-06-22 N200890-003 ISOPTO CARPINE PILOCARPINE HYDROCHLORIDE 4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-06-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N200890-001 ISOPTO CARPINE 1% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N200890-002 ISOPTO CARPINE 2% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N200890-003 ISOPTO CARPINE 4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-06-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200890-001 ISOPTO CARPINE 1% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200890-002 ISOPTO CARPINE 2% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200890-003 ISOPTO CARPINE 4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-06-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N200890-001 ISOPTO CARPINE 1% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200890-002 ISOPTO CARPINE 2% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200890-003 ISOPTO CARPINE 4% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200890-001 ISOPTO CARPINE 1% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200890-002 ISOPTO CARPINE 2% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200890-003 ISOPTO CARPINE 4% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200890-001 ISOPTO CARPINE 1% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200890-002 ISOPTO CARPINE 2% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200890-003 ISOPTO CARPINE 4% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200890-001 ISOPTO CARPINE 1% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200890-002 ISOPTO CARPINE 2% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200890-003 ISOPTO CARPINE 4% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200890-001 ISOPTO CARPINE 1% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200890-002 ISOPTO CARPINE 2% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200890-003 ISOPTO CARPINE 4% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N200890-001 ISOPTO CARPINE 1% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N200890-002 ISOPTO CARPINE 2% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N200890-003 ISOPTO CARPINE 4% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N200890-001 ISOPTO CARPINE 1% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N200890-002 ISOPTO CARPINE 2% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N200890-003 ISOPTO CARPINE 4% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N200890-001 ISOPTO CARPINE 1% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N200890-002 ISOPTO CARPINE 2% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N200890-003 ISOPTO CARPINE 4% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N200890-001 ISOPTO CARPINE 1% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N200890-002 ISOPTO CARPINE 2% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N200890-003 ISOPTO CARPINE 4% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N200890-001 ISOPTO CARPINE 1% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N200890-002 ISOPTO CARPINE 2% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N200890-003 ISOPTO CARPINE 4% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N200890-001 ISOPTO CARPINE 1% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N200890-002 ISOPTO CARPINE 2% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N200890-003 ISOPTO CARPINE 4% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N200890-001 ISOPTO CARPINE 1% SOLUTION / OPHTHALMIC AT RLD, RS 2010-06-22 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Pilocarpine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PILOCARPINE HYDROCHLORIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0WW6D218XJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1000647 Internal RxNorm lookup 1000862 Internal RxNorm lookup 1000897 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61314-203-15 Pilocarpine Hydrochloride 1 in 1 CARTON SOLUTION/ DROPS 1 8 61314-203-15 Pilocarpine Hydrochloride 15 mL in 1 BOTTLE SOLUTION/ DROPS 15 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PILOCARPINE HYDROCHLORIDE ACTIVE INGREDIENT 0WW6D218XJ PILOCARPINE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.] 1 PILOCARPINE HYDROCHLORIDE ACTIVE INGREDIENT 0WW6D218XJ PILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 PILOCARPINE ACTIVE MOIETY 01MI4Q9DI3 PILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 PILOCARPINE ACTIVE MOIETY 01MI4Q9DI3 PILOCARPINE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.] 1 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 PILOCARPINE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.] 1 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 PILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 PILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 PILOCARPINE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB PILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB PILOCARPINE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.] 1 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W PILOCARPINE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X PILOCARPINE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X PILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR PILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR PILOCARPINE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I PILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I PILOCARPINE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PILOCARPINE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61314-203 PILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC] 7 Current NDC, Legacy NDC, 2 package rows 20220630_53fa0b7a-f982-48a7-92c4-6f098683c1ed.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61314-203-15 61314020315 1 BOTTLE in 1 CARTON (61314-203-15) / 15 mL in 1 BOTTLE 1 bottle 2011-09-30 0000-00-00 No No Current