FDA.reportPublic FDA data

meloxicam

Product NDC
68788-8801
11-digit product format
687888801
Labeler code
68788
Product ID
68788-8801_ef3447a9-ed6a-4cba-9681-09ae9dc8b630
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077927
Marketing category
ANDA
Marketing start
2025-01-02
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MELOXICAM15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVG2QF83CGL
Rxcui152695

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
68788-8801-0meloxicam100 in 1 BOTTLETABLET1001
68788-8801-1meloxicam15 in 1 BOTTLETABLET151
68788-8801-2meloxicam20 in 1 BOTTLETABLET201
68788-8801-3meloxicam30 in 1 BOTTLETABLET301
68788-8801-4meloxicam14 in 1 BOTTLETABLET141
68788-8801-6meloxicam60 in 1 BOTTLETABLET601
68788-8801-7meloxicam7 in 1 BOTTLETABLET71
68788-8801-8meloxicam28 in 1 BOTTLETABLET281
68788-8801-9meloxicam90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8801-0EA - Each68788-8801c8179eae-39dc-44c0-aec8-cb91e8067d4a12025-02-10
68788-8801-1EA - Each68788-8801f02932fb-89ae-4488-bf10-cdda5757f16312025-02-10
68788-8801-2EA - Each68788-88013aa64a73-01f2-4fdc-9567-81e8089a142f12025-02-10
68788-8801-3EA - Each68788-8801d06be73d-9fd7-4e69-a659-650618181e1c12025-02-10
68788-8801-4EA - Each68788-8801f6df5526-1fc1-4f49-b2a0-519cd40f2e5e12025-02-10
68788-8801-6EA - Each68788-8801d9c779d1-574c-479a-a6b8-9bf793e5031212025-02-10
68788-8801-7EA - Each68788-8801eb2359bd-6afd-4b6e-8dbd-c3eebc0918ae12025-02-10
68788-8801-8EA - Each68788-8801e744741a-9a81-4f2e-9a0b-bb19a8548afd12025-02-10
68788-8801-9EA - Each68788-88015cf4237b-2d68-4464-87e5-47a3c78489ae12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8801MELOXICAM TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 9 package rows20250104_ef3447a9-ed6a-4cba-9681-09ae9dc8b630.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSNef3447a9-ed6a-4cba-9681-09ae9dc8b6301
152695meloxicam 15 MG Oral TabletSCDef3447a9-ed6a-4cba-9681-09ae9dc8b6301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8801-068788880100100 TABLET in 1 BOTTLE (68788-8801-0) 100 tablet2025-01-02NoNoCurrent
68788-8801-16878888010115 TABLET in 1 BOTTLE (68788-8801-1) 15 tablet2025-01-02NoNoCurrent
68788-8801-26878888010220 TABLET in 1 BOTTLE (68788-8801-2) 20 tablet2025-01-02NoNoCurrent
68788-8801-36878888010330 TABLET in 1 BOTTLE (68788-8801-3) 30 tablet2025-01-02NoNoCurrent
68788-8801-46878888010414 TABLET in 1 BOTTLE (68788-8801-4) 14 tablet2025-01-02NoNoCurrent
68788-8801-66878888010660 TABLET in 1 BOTTLE (68788-8801-6) 60 tablet2025-01-02NoNoCurrent
68788-8801-7687888801077 TABLET in 1 BOTTLE (68788-8801-7) 7 tablet2025-01-02NoNoCurrent
68788-8801-86878888010828 TABLET in 1 BOTTLE (68788-8801-8) 28 tablet2025-01-02NoNoCurrent
68788-8801-96878888010990 TABLET in 1 BOTTLE (68788-8801-9) 90 tablet2025-01-02NoNoCurrent