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

Additional Listing Data#

Finished product
Yes
Brand name base
Pilocarpine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PILOCARPINE HYDROCHLORIDE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0WW6D218XJ
Rxcui1000913, 1001004

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
92fc48b4-3815-4611-a8be-f74b29f9b350Product name220260130
c8f45a17-34ae-46eb-871b-470615085910Product name120250630
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
dad00d81-2cbe-bbab-dd06-a12043b5e56dProduct name420210512
419b812f-d1a6-2de2-5dee-bec68d6ec699Product name220200123
38c480e0-b6d3-b416-6514-a787406e5176Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0527-1407-012024-01-30C16284748780-11030e365-3903-111a-e063-dadaa90a10e2Pilocarpine Hydrochloride Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-1407-01Pilocarpine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1407-01EA - Each0527-1407e9e902ba-a943-4337-87a9-912cef6898a512012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1407PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.]18Current NDC, Legacy NDC, 1 package rows20241109_8db0db4f-55ad-46b2-af50-e71b4a763aaa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000913pilocarpine HCl 5 MG Oral TabletPSN8db0db4f-55ad-46b2-af50-e71b4a763aaa18
1001004pilocarpine HCl 7.5 MG Oral TabletPSN8db0db4f-55ad-46b2-af50-e71b4a763aaa18
1000913pilocarpine hydrochloride 5 MG Oral TabletSCD8db0db4f-55ad-46b2-af50-e71b4a763aaa18
1001004pilocarpine hydrochloride 7.5 MG Oral TabletSCD8db0db4f-55ad-46b2-af50-e71b4a763aaa18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0527-1407-0100527140701100 TABLET, FILM COATED in 1 BOTTLE (0527-1407-01) 2005-10-140000-00-00NoNoCurrent