FDA.reportPublic FDA data

Etodolac

Product NDC
70332-320
11-digit product format
703320320
Labeler code
70332
Product ID
70332-320_5d135044-5ff9-180a-e053-2991aa0ab763
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
California Pharmaceuticals, LLC
Application
ANDA091134
Marketing category
ANDA
Marketing start
2017-08-03
Marketing end
0000-00-00
Substance
ETODOLAC
Active strength
600 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bb9faa76-10d1-4b5f-ab9b-d6a26495edb7Product name120250311
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
0c3d95a8-02c3-425e-810b-2a14408d9a06Product name420250218
24aa5265-325f-0e21-8836-2c9a907c0454Product name220210601
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70332-320-012020-01-31C16284748780-19d75b9d0-16e1-f424-e053-dadaa90a57ceEtodolac Extended-Release 600mg Tablets, USP (Repackaged)
70332-320-022020-01-31C16284748780-19d75b9d0-16e1-f424-e053-dadaa90a57ceEtodolac Extended-Release 600mg Tablets, USP (Repackaged)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70332-320-01Etodolac7 in 1 BOTTLE, UNIT-DOSETABLET, FILM COATED, EXTENDED RE72
70332-320-02Etodolac30 in 1 BOTTLE, UNIT-DOSETABLET, FILM COATED, EXTENDED RE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70332-320-01EA - Each70332-3206fd7a736-79be-4342-98ad-32d60ed5f8f512017-09-11
70332-320-02EA - Each70332-32078a16cb5-5e36-4c14-9376-ee75b51d124012017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70332-320ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [CALIFORNIA PHARMACEUTICALS, LLC]2Legacy NDC, 2 package rows20171103_55df91c5-d3cc-3443-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310247etodolac 600 MG 24HR Extended Release Oral TabletPSN55df91c5-d3cc-3443-e054-00144ff8d46c2
31024724 HR etodolac 600 MG Extended Release Oral TabletSCD55df91c5-d3cc-3443-e054-00144ff8d46c2
310247etodolac 600 MG 24 HR Extended Release Oral TabletSY55df91c5-d3cc-3443-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
70332-320-01703320320017 in 1 BOTTLE, UNIT-DOSEHistorical
70332-320-027033203200230 in 1 BOTTLE, UNIT-DOSEHistorical