Home NDC 0115-5922 Pilocarpine Hydrochloride
Product NDC 0115-5922
11-digit product format 001155922
Labeler code 0115
Product ID 0115-5922_6623703f-52d6-48ad-881b-2d20d4c0989d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PILOCARPINE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA077248
Marketing category ANDA
Marketing start 2007-05-01
Marketing end 0000-00-00
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 2021-12-31
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 · 45 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A077248-001 PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-03-31 A077248-002 PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-03-31
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 A077248-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-03-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077248-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077248-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-03-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077248-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077248-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-03-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077248-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077248-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-03-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077248-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-03-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077248-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-03-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077248-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-03-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077248-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-03-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077248-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-03-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077248-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-03-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077248-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-03-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077248-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-03-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077248-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-03-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077248-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-03-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077248-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-03-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077248-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-03-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077248-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-03-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077248-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-03-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077248-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-03-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077248-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-03-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077248-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-03-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077248-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-03-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077248-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-03-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077248-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-03-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077248-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-03-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077248-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-03-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077248-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-03-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077248-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-03-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077248-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-03-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077248-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-03-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077248-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-03-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077248-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-03-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077248-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-03-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077248-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-03-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077248-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-03-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077248-001 PILOCARPINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-03-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077248-002 PILOCARPINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-03-31 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 0115-5922-01 Pilocarpine Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 14 0115-5922-03 Pilocarpine Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 14
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 [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 PILOCARPINE ACTIVE MOIETY 01MI4Q9DI3 PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 Pilocarpine Hydrochloride ACTIVE INGREDIENT 0WW6D218XJ PILOCARPINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 Pilocarpine ACTIVE MOIETY 01MI4Q9DI3 PILOCARPINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PILOCARPINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE PILOCARPINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A PILOCARPINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PILOCARPINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP PILOCARPINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP PILOCARPINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 triacetin INACTIVE INGREDIENT XHX3C3X673 PILOCARPINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0115-5922 PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 14 Legacy NDC, 2 package rows 20201230_3a0de319-5390-426c-9c71-76acc03735c7.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 · 1 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 0115-5922-01 00115592201 100 TABLET, FILM COATED in 1 BOTTLE (0115-5922-01) 2007-05-01 0000-00-00 No No Current 0115-5922-03 00115592203 1000 TABLET, FILM COATED in 1 BOTTLE (0115-5922-03) 2007-05-01 0000-00-00 No No Current