Etodolac

Product NDC
63629-1936
11-digit product format
636291936
Labeler code
63629
Product ID
63629-1936_8239727c-673f-4490-a644-872da0af3d39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075126
Marketing category
ANDA
Marketing start
2015-02-01
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
Rxcui197685

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
63629-1936-1Etodolac100 in 1 BOTTLECAPSULE100105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1936-1EA - Each63629-193682ca5ee5-6bf2-49c0-827e-d6ed87c3b7ca12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1936ETODOLAC CAPSULE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 1 package rows20240822_b7f7c4a4-6245-43e1-af40-fcf61abbc64e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197685etodolac 300 MG Oral CapsulePSNb7f7c4a4-6245-43e1-af40-fcf61abbc64e105
197685etodolac 300 MG Oral CapsuleSCDb7f7c4a4-6245-43e1-af40-fcf61abbc64e105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1936-163629193601100 CAPSULE in 1 BOTTLE (63629-1936-1) 100 capsule2021-06-290000-00-00NoNoCurrent