Etodolac

Product NDC
43063-671
11-digit product format
430630671
Labeler code
43063
Product ID
43063-671_511888b4-8fc4-6348-e063-6394a90a21bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA076004
Marketing category
ANDA
Marketing start
2003-05-01
Substance
ETODOLAC
Active strength
500 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
ETODOLAC500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2M36281008
Rxcui199390

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
43063-671-30Etodolac30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-671-30EA - Each43063-671a5e67268-9b6d-466c-a296-f74c43dce71912018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-671ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]16Current NDC, Legacy NDC, 1 package rows20240925_41bd86b9-2ef3-49a4-874e-fe8ac6891080.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199390etodolac 500 MG Oral TabletPSN41bd86b9-2ef3-49a4-874e-fe8ac689108018
199390etodolac 500 MG Oral TabletSCD41bd86b9-2ef3-49a4-874e-fe8ac689108018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-671-304306306713030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-671-30) 2018-01-160000-00-00NoNoCurrent