Etodolac

Product NDC
63629-3641
11-digit product format
636293641
Labeler code
63629
Product ID
63629-3641_36d35f56-5910-4774-8dab-8faca4101c5d
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
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-3641-1Etodolac60 in 1 BOTTLECAPSULE606
63629-3641-2Etodolac90 in 1 BOTTLECAPSULE906
63629-3641-3Etodolac18 in 1 BOTTLECAPSULE186

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197684etodolac 200 MG Oral CapsulePSNe7a81661-28a2-40d7-8c90-786629c81e366
197684etodolac 200 MG Oral CapsuleSCDe7a81661-28a2-40d7-8c90-786629c81e366

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3641-16362936410160 CAPSULE in 1 BOTTLE (63629-3641-1) 60 capsule2017-05-150000-00-00NoNoCurrent
63629-3641-26362936410290 CAPSULE in 1 BOTTLE (63629-3641-2) 90 capsule2021-12-220000-00-00NoNoCurrent
63629-3641-36362936410318 CAPSULE in 1 BOTTLE (63629-3641-3) 18 capsule2021-12-220000-00-00NoNoCurrent