Home NDC 59212-775 Salagen
Product NDC 59212-775
11-digit product format 592120775
Labeler code 59212
Product ID 59212-775_5e2a19b9-0694-43ac-9e0e-b40048495a1b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pilocarpine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Advanz Pharma (US) Corp.
Application NDA020237
Marketing category NDA
Marketing start 2019-09-01
Substance PILOCARPINE HYDROCHLORIDE
Active strength 7.5 mg/1
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 · 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 · 82 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 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…2019-12-13 00:20 UTC 2019-12 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020237-001 SALAGEN 5MG TABLET / ORAL AB RLD 1994-03-22 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020237-002 SALAGEN 7.5MG TABLET / ORAL AB RLD, RS 2003-04-18 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Salagen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PILOCARPINE HYDROCHLORIDE 7.5 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1000913 Internal RxNorm lookup 1000915 Internal RxNorm lookup 1001004 Internal RxNorm lookup 1001006 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 59212-775-10 Salagen 100 in 1 BOTTLE TABLET, FILM COATED 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59212-775 SALAGEN (PILOCARPINE HYDROCHLORIDE) TABLET, FILM COATED [ADVANZ PHARMA (US) CORP.] 4 Current NDC, Legacy NDC, 1 package rows 20241220_62eda83d-d043-4c7e-8fcf-75d05efbf35b.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 Marketing start Marketing end Sample Exclude flag Status 59212-775-10 59212077510 100 TABLET, FILM COATED in 1 BOTTLE (59212-775-10) 2019-09-01 0000-00-00 No No Current