FDA.reportPublic FDA data

Etodolac

Product NDC
71205-743
11-digit product format
712050743
Labeler code
71205
Product ID
71205-743_0fce1aea-5de2-4acb-8a21-2b775c4adb25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
24aa5265-325f-0e21-8836-2c9a907c0454Product name220210601

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-743-20Etodolac20 in 1 BOTTLECAPSULE201
71205-743-30Etodolac30 in 1 BOTTLECAPSULE301
71205-743-60Etodolac60 in 1 BOTTLECAPSULE601
71205-743-90Etodolac90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-743-90EA - Each71205-743c271df3b-9bff-481b-b129-69bd2b65aa1612023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-743ETODOLAC CAPSULE [PROFICIENT RX LP]1Current NDC, 4 package rows20230124_0fce1aea-5de2-4acb-8a21-2b775c4adb25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197684etodolac 200 MG Oral CapsulePSN0fce1aea-5de2-4acb-8a21-2b775c4adb251
197684etodolac 200 MG Oral CapsuleSCD0fce1aea-5de2-4acb-8a21-2b775c4adb251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-743-207120507432020 CAPSULE in 1 BOTTLE (71205-743-20) 20 capsule2023-01-16NoNoHistorical
71205-743-307120507433030 CAPSULE in 1 BOTTLE (71205-743-30) 30 capsule2023-01-16NoNoHistorical
71205-743-607120507436060 CAPSULE in 1 BOTTLE (71205-743-60) 60 capsule2023-01-16NoNoHistorical
71205-743-907120507439090 CAPSULE in 1 BOTTLE (71205-743-90) 90 capsule2023-01-16NoNoHistorical