FDA.reportPublic FDA data

Vivlodex

Product NDC
69344-206
11-digit product format
693440206
Labeler code
69344
Product ID
69344-206_3de1cbf0-3e23-4095-8e5b-b8e0039667bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meloxicam
Dosage form
CAPSULE
Route
ORAL
Labeler
Egalet US Inc.
Application
NDA207233
Marketing category
NDA
Marketing start
2019-02-04
Marketing end
0000-00-00
Substance
MELOXICAM
Active strength
10 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bdef11ce-16e2-4690-96a3-597bcf5cc738Product name120260130
f2791553-0b76-42f4-8d49-af3eda072bfbProduct name120251117
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
3e9b4ed6-844c-4725-9d19-cceb5c823572Product name220210903
b21a682e-c765-4e26-9bb2-dbb8c7b38ef7Product name120200623
a428d1db-64d7-4fc3-8d13-832b1e84b683Product name120190201
96649a58-aac8-401c-be00-450b4335f7e7Product name120161116
f0761cb7-8207-3a19-2ca3-ecbb559b04e1Product name220161116

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69344-206-232023-01-30C16284748780-1f386c649-a5cc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VIVLODEX™ safely and effectively. See full prescribing information for VIVLODEX. VIVLODEX (meloxicam) capsules, for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69344-206-23Vivlodex30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69344-206-23EA - Each69344-20615915998-d774-4765-866e-5bea381f88a612019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69344-206VIVLODEX (MELOXICAM) CAPSULE [EGALET US INC.]3Legacy NDC, 1 package rows20210512_11771dcf-0803-4de9-a2fe-73edec256209.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722357meloxicam 10 MG Oral CapsulePSN11771dcf-0803-4de9-a2fe-73edec2562093
1722349meloxicam 5 MG Oral CapsulePSN11771dcf-0803-4de9-a2fe-73edec2562093
1722359Vivlodex 10 MG Oral CapsulePSN11771dcf-0803-4de9-a2fe-73edec2562093
1722355Vivlodex 5 MG Oral CapsulePSN11771dcf-0803-4de9-a2fe-73edec2562093
1722359meloxicam 10 MG Oral Capsule [Vivlodex]SBD11771dcf-0803-4de9-a2fe-73edec2562093
1722355meloxicam 5 MG Oral Capsule [Vivlodex]SBD11771dcf-0803-4de9-a2fe-73edec2562093
1722357meloxicam 10 MG Oral CapsuleSCD11771dcf-0803-4de9-a2fe-73edec2562093
1722349meloxicam 5 MG Oral CapsuleSCD11771dcf-0803-4de9-a2fe-73edec2562093
1722359Vivlodex 10 MG Oral CapsuleSY11771dcf-0803-4de9-a2fe-73edec2562093
1722355Vivlodex 5 MG Oral CapsuleSY11771dcf-0803-4de9-a2fe-73edec2562093

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69344-206-236934402062330 CAPSULE in 1 BOTTLE (69344-206-23) 30 capsule2019-02-040000-00-00NoNoCurrent