Home NDC 0998-0206-15 ISOPTO CARPINE
Product NDC 0998-0206
Requested package NDC 0998-0206-15
11-digit product format 009980206
Labeler code 0998
Product ID 0998-0206_b07b9126-1edd-4fbe-b68d-a03533346dad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pilocarpine hydrochloride
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Alcon Laboratories, Inc.
Application NDA200890
Marketing category NDA
Marketing start 1974-01-01
Marketing end 2022-05-31
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 0000-00-00
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PILOCARPINE HYDROCHLORIDE ACTIVE INGREDIENT 0WW6D218XJ ISOPTO CARPINE (PILOCARPINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.] 7 PILOCARPINE ACTIVE MOIETY 01MI4Q9DI3 ISOPTO CARPINE (PILOCARPINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.] 7 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 ISOPTO CARPINE (PILOCARPINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.] 7 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 ISOPTO CARPINE (PILOCARPINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.] 7 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB ISOPTO CARPINE (PILOCARPINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.] 7 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W ISOPTO CARPINE (PILOCARPINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.] 7 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X ISOPTO CARPINE (PILOCARPINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.] 7 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ISOPTO CARPINE (PILOCARPINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.] 7 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ISOPTO CARPINE (PILOCARPINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.] 7 WATER INACTIVE INGREDIENT 059QF0KO0R ISOPTO CARPINE (PILOCARPINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.] 7
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0998-0206-15 00998020615 1 BOTTLE in 1 CARTON (0998-0206-15) > 15 mL in 1 BOTTLE 1 bottle 1974-01-01 2022-05-31 No No Current