FDA.reportPublic FDA data

Etodolac

Product NDC
43063-856
11-digit product format
430630856
Labeler code
43063
Product ID
43063-856_526a51f5-1d45-fd3c-e063-6394a90a2fd1
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
400 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
ETODOLAC400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2M36281008
Rxcui197686

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
43063-856-20Etodolac20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2026
43063-856-30Etodolac30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3026
43063-856-60Etodolac60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-856-20EA - Each43063-856007757c3-e78a-49cd-87ea-bd665961f68712018-07-03
43063-856-30EA - Each43063-856f323e7eb-5e78-4896-9ea5-8b9d8720c8d112018-08-13
43063-856-60EA - Each43063-856596ed778-84fe-457c-a77a-1e40d8c99e3c12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-856ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]24Current NDC, Legacy NDC, 3 package rows20250112_007c55fa-ef8b-4a8e-bfe5-e47c6e5da727.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSN007c55fa-ef8b-4a8e-bfe5-e47c6e5da72726
197686etodolac 400 MG Oral TabletSCD007c55fa-ef8b-4a8e-bfe5-e47c6e5da72726

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-856-204306308562020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-856-20) 2018-05-310000-00-00NoNoCurrent
43063-856-304306308563030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-856-30) 2018-06-270000-00-00NoNoCurrent
43063-856-604306308566060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-856-60) 2018-11-010000-00-00NoNoCurrent