Home NDC 72162-1078 Pilocarpine Hydrochloride
Product NDC 72162-1078
11-digit product format 721621078
Labeler code 72162
Product ID 72162-1078_aa0c11f4-3998-4089-80b7-b6807c77ecd3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pilocarpine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA077220
Marketing category ANDA
Marketing start 2005-10-14
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
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 A077220-001 PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2005-10-14 A077220-002 PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2009-05-06
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 A077220-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2005-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077220-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2009-05-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077220-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2005-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077220-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2009-05-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077220-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2005-10-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077220-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2009-05-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077220-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2005-10-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077220-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2009-05-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077220-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2005-10-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077220-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2009-05-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077220-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2005-10-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077220-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2009-05-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077220-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2005-10-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077220-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2009-05-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077220-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2005-10-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077220-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2009-05-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077220-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2005-10-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077220-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2009-05-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077220-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2005-10-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077220-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2009-05-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077220-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2005-10-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077220-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2009-05-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077220-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2005-10-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077220-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2009-05-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077220-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2005-10-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077220-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2009-05-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077220-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2005-10-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077220-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2009-05-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077220-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2005-10-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077220-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2009-05-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077220-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2005-10-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077220-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2009-05-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077220-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2005-10-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077220-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2009-05-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077220-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2005-10-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077220-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2009-05-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077220-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2005-10-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077220-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2009-05-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077220-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2005-10-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077220-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2009-05-06 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 Pilocarpine Hydrochloride
Listing expiration 2026-12-31 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 72162-1078-1 Pilocarpine Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 101
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-1078 PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 101 Current NDC, 1 package rows 20241226_06c054af-62b4-4373-813a-9bb2e5c92316.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 · 5 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72162-1078-1 72162107801 100 TABLET, FILM COATED in 1 BOTTLE (72162-1078-1) 2024-12-12 No No Current