Pilocarpine Hydrochloride

Product NDC
10135-680
11-digit product format
101350680
Labeler code
10135
Product ID
10135-680_ab361398-0213-4453-a29e-2f6215e3a7cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pilocarpine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA076963
Marketing category
ANDA
Marketing start
2019-02-01
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
92fc48b4-3815-4611-a8be-f74b29f9b350Product name220260130
c8f45a17-34ae-46eb-871b-470615085910Product name120250630
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
10135-680-012021-01-29C16284748780-1ba0f9c33-1a78-a910-e053-dadaa90a0b85Pilocarpine Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-680-01Pilocarpine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-680-01EA - Each10135-6809320387b-58a2-4bfd-b177-ef4b24a1ff9912019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-680PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]1Legacy NDC, 1 package rows20190227_4b856409-ee10-455b-a0f3-69c65df69123.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000913pilocarpine HCl 5 MG Oral TabletPSN4b856409-ee10-455b-a0f3-69c65df691231
1000913pilocarpine hydrochloride 5 MG Oral TabletSCD4b856409-ee10-455b-a0f3-69c65df691231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-680-0110135068001100 in 1 BOTTLEHistorical