FDA.reportPublic FDA data

Etodolac

Product NDC
71335-1958
11-digit product format
713351958
Labeler code
71335
Product ID
71335-1958_45dc5310-0271-4d79-bfe3-5a4dcf71c6ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075074
Marketing category
ANDA
Marketing start
1998-03-11
Substance
ETODOLAC
Active strength
400 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Etodolac
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETODOLAC400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2M36281008
Rxcui197686

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bb9faa76-10d1-4b5f-ab9b-d6a26495edb7Product name120250311
0c3d95a8-02c3-425e-810b-2a14408d9a06Product name420250218
24aa5265-325f-0e21-8836-2c9a907c0454Product name220210601

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1958-1Etodolac20 in 1 BOTTLETABLET, FILM COATED20102
71335-1958-2Etodolac14 in 1 BOTTLETABLET, FILM COATED14102
71335-1958-3Etodolac30 in 1 BOTTLETABLET, FILM COATED30102
71335-1958-4Etodolac100 in 1 BOTTLETABLET, FILM COATED100102
71335-1958-5Etodolac60 in 1 BOTTLETABLET, FILM COATED60102
71335-1958-6Etodolac90 in 1 BOTTLETABLET, FILM COATED90102
71335-1958-7Etodolac56 in 1 BOTTLETABLET, FILM COATED56102
71335-1958-8Etodolac120 in 1 BOTTLETABLET, FILM COATED120102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1958-1EA - Each71335-1958cfe6796e-6bc0-4b91-9d4f-5379a2e19f8b12026-04-20
71335-1958-2EA - Each71335-1958f59b487a-e83d-4fce-922b-58072c6255ab12026-04-20
71335-1958-3EA - Each71335-1958061db1d0-de90-4d4d-9829-40f44be311e412026-04-20
71335-1958-4EA - Each71335-1958e3bc1e35-4152-4fde-88c5-fc419adde2c512026-04-20
71335-1958-5EA - Each71335-195853c0b0c9-c9dc-40a5-8bcd-0fd04d76824312026-04-20
71335-1958-6EA - Each71335-1958529df53c-dcb3-4a6e-bb6e-45bd7b39babb12026-04-20
71335-1958-7EA - Each71335-1958474c5157-b6e4-4fd9-9bfb-c55336b5fb6212026-04-20
71335-1958-8EA - Each71335-19581bdfd101-d644-4c9a-9c08-9b4c3a8810a612026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSN03458123-e27c-4447-9ef3-3bd32481cb97102
197686etodolac 400 MG Oral TabletSCD03458123-e27c-4447-9ef3-3bd32481cb97102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1958-17133519580120 TABLET, FILM COATED in 1 BOTTLE (71335-1958-1) 2021-10-060000-00-00NoNoCurrent
71335-1958-27133519580214 TABLET, FILM COATED in 1 BOTTLE (71335-1958-2) 2021-10-060000-00-00NoNoCurrent
71335-1958-37133519580330 TABLET, FILM COATED in 1 BOTTLE (71335-1958-3) 2021-10-060000-00-00NoNoCurrent
71335-1958-471335195804100 TABLET, FILM COATED in 1 BOTTLE (71335-1958-4) 2021-10-060000-00-00NoNoCurrent
71335-1958-57133519580560 TABLET, FILM COATED in 1 BOTTLE (71335-1958-5) 2021-10-060000-00-00NoNoCurrent
71335-1958-67133519580690 TABLET, FILM COATED in 1 BOTTLE (71335-1958-6) 2021-10-060000-00-00NoNoCurrent
71335-1958-77133519580756 TABLET, FILM COATED in 1 BOTTLE (71335-1958-7) 2021-10-060000-00-00NoNoCurrent
71335-1958-871335195808120 TABLET, FILM COATED in 1 BOTTLE (71335-1958-8) 2021-10-060000-00-00NoNoCurrent