Etodolac

Product NDC
60505-0040
11-digit product format
605050040
Labeler code
60505
Product ID
60505-0040_41e18dea-7642-9715-53b0-db2b46d8265b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA075419
Marketing category
ANDA
Marketing start
2003-05-01
Substance
ETODOLAC
Active strength
300 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETODOLAC300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2M36281008
Rxcui197684, 197685

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
60505-0040-1Etodolac100 in 1 BOTTLECAPSULE10013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0040ETODOLAC CAPSULE [APOTEX CORP.]12Current NDC, Legacy NDC, 1 package rows20240809_86c7b7b8-3a98-e5f4-c558-5b5caede6377.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197684etodolac 200 MG Oral CapsulePSN86c7b7b8-3a98-e5f4-c558-5b5caede637713
197685etodolac 300 MG Oral CapsulePSN86c7b7b8-3a98-e5f4-c558-5b5caede637713
197685etodolac 300 MG Oral CapsulePSNc2391373-9b5f-4eb9-b595-2439b15d2fbb13
197684etodolac 200 MG Oral CapsuleSCD86c7b7b8-3a98-e5f4-c558-5b5caede637713
197685etodolac 300 MG Oral CapsuleSCD86c7b7b8-3a98-e5f4-c558-5b5caede637713
197685etodolac 300 MG Oral CapsuleSCDc2391373-9b5f-4eb9-b595-2439b15d2fbb13
197685etodolac 300 MG Oral CapsulePSN7ec87ffd-057e-420c-b8f2-0a6eed4152be4
197685etodolac 300 MG Oral CapsuleSCD7ec87ffd-057e-420c-b8f2-0a6eed4152be4
197685etodolac 300 MG Oral CapsulePSN85b6254b-21da-ea85-e053-2991aa0a7d512
197685etodolac 300 MG Oral CapsuleSCD85b6254b-21da-ea85-e053-2991aa0a7d512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0040-160505004001100 CAPSULE in 1 BOTTLE (60505-0040-1) 100 capsule2003-05-010000-00-00NoNoCurrent