Etodolac

Product NDC
51655-166
11-digit product format
516550166
Labeler code
51655
Product ID
51655-166_48c3f545-4ae6-d18f-e063-6294a90acb45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA075419
Marketing category
ANDA
Marketing start
2014-11-13
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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-166-522023-07-05C16284748780-19d75b9d0-6694-f424-e053-dadaa90a57ceEtodolac Capsules, USP 300 mg Rx only
51655-166-522020-01-31C16284748780-19d75b9d0-6694-f424-e053-dadaa90a57ceEtodolac Capsules, USP 300 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-166-52Etodolac30 in 1 BOTTLE, DISPENSINGCAPSULE304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETODOLACACTIVE INGREDIENT2M36281008ETODOLAC CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]1
ETODOLACACTIVE MOIETY2M36281008ETODOLAC CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-166ETODOLAC CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 1 package rows20241215_7ec87ffd-057e-420c-b8f2-0a6eed4152be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197685etodolac 300 MG Oral CapsulePSN7ec87ffd-057e-420c-b8f2-0a6eed4152be4
197685etodolac 300 MG Oral CapsuleSCD7ec87ffd-057e-420c-b8f2-0a6eed4152be4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-166-525165501665230 CAPSULE in 1 BOTTLE, DISPENSING (51655-166-52) 30 capsule2014-11-13NoNoHistorical