FDA.reportPublic FDA data

meloxicam

Product NDC
68788-7904
11-digit product format
687887904
Labeler code
68788
Product ID
68788-7904_620e49d9-e298-4907-bb3c-2787e18c2314
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077921
Marketing category
ANDA
Marketing start
2021-05-14
Substance
MELOXICAM
Active strength
15 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
meloxicam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MELOXICAM15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVG2QF83CGL

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7904-1meloxicam15 in 1 BOTTLETABLET155
68788-7904-3meloxicam30 in 1 BOTTLETABLET305
68788-7904-6meloxicam60 in 1 BOTTLETABLET605
68788-7904-9meloxicam90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7904-1EA - Each68788-79046068e1be-60fd-4e38-bec6-7537a912071812021-07-15
68788-7904-3EA - Each68788-790471775ee4-85f8-495f-a52e-15bab944c6b012021-07-15
68788-7904-6EA - Each68788-79048cc1ae69-491e-4a72-b74d-ee792058116712021-07-15
68788-7904-9EA - Each68788-7904702cb273-a2cd-4553-a616-3363ddf7393112021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7904MELOXICAM TABLET [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 4 package rows20240704_e0deb1f7-b575-463f-a3f8-304cc1936075.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSNe0deb1f7-b575-463f-a3f8-304cc19360755
152695meloxicam 15 MG Oral TabletSCDe0deb1f7-b575-463f-a3f8-304cc19360755

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7904-16878879040115 TABLET in 1 BOTTLE (68788-7904-1) 15 tablet2021-05-140000-00-00NoNoCurrent
68788-7904-36878879040330 TABLET in 1 BOTTLE (68788-7904-3) 30 tablet2021-05-140000-00-00NoNoCurrent
68788-7904-66878879040660 TABLET in 1 BOTTLE (68788-7904-6) 60 tablet2021-05-140000-00-00NoNoCurrent
68788-7904-96878879040990 TABLET in 1 BOTTLE (68788-7904-9) 90 tablet2021-05-140000-00-00NoNoCurrent