Home NDC 0527-1407 Pilocarpine Hydrochloride
Product NDC 0527-1407
11-digit product format 005271407
Labeler code 0527
Product ID 0527-1407_3062d101-0b98-4101-8f53-13ae694873fe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pilocarpine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA077220
Marketing category ANDA
Marketing start 2005-10-14
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 42 .
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 · 84 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 2026-08-18 06:07:40 2026-07 A077220-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2005-10-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077220-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2009-05-06 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1000913 Internal RxNorm lookup 1001004 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0527-1407-01 Pilocarpine Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 18
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 [LANNETT COMPANY, INC.] 11 PILOCARPINE ACTIVE MOIETY 01MI4Q9DI3 PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 11 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 11 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 11 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 11 INDIGOTINDISULFONATE SODIUM INACTIVE INGREDIENT D3741U8K7L PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 11 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 11 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 11 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 11 TALC INACTIVE INGREDIENT 7SEV7J4R1U PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0527-1407 PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] 18 Current NDC, Legacy NDC, 1 package rows 20241109_8db0db4f-55ad-46b2-af50-e71b4a763aaa.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 Marketing end Sample Exclude flag Status 0527-1407-01 00527140701 100 TABLET, FILM COATED in 1 BOTTLE (0527-1407-01) 2005-10-14 0000-00-00 No No Current