Etodolac

Product NDC
71335-3119
11-digit product format
713353119
Labeler code
71335
Product ID
71335-3119_24b80ca8-c835-44c1-b73a-d9a3d5ecd0fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075078
Marketing category
ANDA
Marketing start
1998-04-30
Substance
ETODOLAC
Active strength
200 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
ETODOLAC200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2M36281008
Rxcui197684

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
71335-3119-1Etodolac60 in 1 BOTTLECAPSULE601
71335-3119-2Etodolac90 in 1 BOTTLECAPSULE901
71335-3119-3Etodolac18 in 1 BOTTLECAPSULE181

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197684etodolac 200 MG Oral CapsulePSNea12933b-2280-4a11-a0e3-554194c53c4d1
197684etodolac 200 MG Oral CapsuleSCDea12933b-2280-4a11-a0e3-554194c53c4d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3119-17133531190160 CAPSULE in 1 BOTTLE (71335-3119-1) 60 capsule2026-03-30NoNoCurrent
71335-3119-27133531190290 CAPSULE in 1 BOTTLE (71335-3119-2) 90 capsule2026-03-30NoNoCurrent
71335-3119-37133531190318 CAPSULE in 1 BOTTLE (71335-3119-3) 18 capsule2026-03-30NoNoCurrent