Etodolac

Product NDC
63629-1935
11-digit product format
636291935
Labeler code
63629
Product ID
63629-1935_bf0cfcce-f184-4ed7-9117-07aeeae12739
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075126
Marketing category
ANDA
Marketing start
2015-03-09
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
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
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
63629-1935-1Etodolac100 in 1 BOTTLECAPSULE100106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1935-1EA - Each63629-1935e631441b-5b36-4992-9495-d09ca301863512021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1935ETODOLAC CAPSULE [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 1 package rows20240814_dbaa1202-1ade-4471-96fb-4b951b386234.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197684etodolac 200 MG Oral CapsulePSNdbaa1202-1ade-4471-96fb-4b951b386234106
197684etodolac 200 MG Oral CapsuleSCDdbaa1202-1ade-4471-96fb-4b951b386234106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1935-163629193501100 CAPSULE in 1 BOTTLE (63629-1935-1) 100 capsule2021-06-290000-00-00NoNoCurrent