Home NDC 68084-928-25 Pilocarpine hydrochloride
Product NDC 68084-928
Requested package NDC 68084-928-25
11-digit product format 680840928
Labeler code 68084
Product ID 68084-928_4911bf7f-0c0c-fde7-e063-6394a90ac636
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pilocarpine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler American Health Packaging
Application NDA020237
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2015-09-25
Marketing end 2027-02-28
Substance PILOCARPINE HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020237-001 SALAGEN PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB RLD 1994-03-22 N020237-002 SALAGEN PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 88 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 2026-10-15 13:18:30 2026-09 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 c2088c7a36db…2026-09-14 22:38:34 2026-08 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Pilocarpine hydrochloride Active Ingredients# Ingredient, Strength table Ingredient Strength PILOCARPINE HYDROCHLORIDE 5 mg/1
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1000913 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 68084-928-25 Pilocarpine hydrochloride 30 in 1 BOX, UNIT-DOSE TABLET, FILM COATED 30 8 68084-928-95 Pilocarpine hydrochloride 1 in 1 BLISTER PACK TABLET, FILM COATED 1 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PILOCARPINE HYDROCHLORIDE ACTIVE INGREDIENT 0WW6D218XJ PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 PILOCARPINE ACTIVE MOIETY 01MI4Q9DI3 PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68084-928 PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 7 Current NDC, Legacy NDC, 2 package rows 20250109_6f950741-fd3f-4bf7-83b0-f5aa9dbceb76.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 · 3 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 68084-928-25 68084092825 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-928-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-928-95) 30 blister pack 2015-09-25 2027-02-28 No No Current