Etodolac

Product NDC
43063-834
11-digit product format
430630834
Labeler code
43063
Product ID
43063-834_d683ce9c-195f-233f-e053-2a95a90a85f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
TABLET, COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA074903
Marketing category
ANDA
Marketing start
2015-04-20
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-834-60EA - Each43063-834d9dce797-837a-4fbb-a0f0-0e25a9c48bf412018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-834ETODOLAC TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]19Legacy NDC20241017_719ff8a0-fbf3-46f6-86eb-d6b7b0cc66dc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-834-604306308346060 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-834-60) 2018-02-060000-00-00NoNoCurrent