FDA.reportPublic FDA data

meloxicam

Product NDC
43063-401
11-digit product format
430630401
Labeler code
43063
Product ID
43063-401_4d5307ad-6c4f-912a-e063-6394a90a2c62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077927
Marketing category
ANDA
Marketing start
2007-03-07
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
2027-12-31
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
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
43063-401-14meloxicam14 in 1 BOTTLE, PLASTICTABLET1422
43063-401-15meloxicam15 in 1 BOTTLE, PLASTICTABLET1522
43063-401-28meloxicam28 in 1 BOTTLE, PLASTICTABLET2822
43063-401-30meloxicam30 in 1 BOTTLE, PLASTICTABLET3022
43063-401-60meloxicam60 in 1 BOTTLE, PLASTICTABLET6022
43063-401-90meloxicam90 in 1 BOTTLE, PLASTICTABLET9022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-401-14EA - Each43063-40148ed1d2c-0807-4a7d-af2c-efcbe58c2d1d12020-08-06
43063-401-15EA - Each43063-401ce9f52bf-e007-4de5-8161-1660babec61012013-02-13
43063-401-28EA - Each43063-401e416e837-ba52-4000-9f45-479139c9cc3512019-11-12
43063-401-30EA - Each43063-4010ab4a666-a5fe-4a63-9f24-a417abdeffb412021-01-08
43063-401-60EA - Each43063-4019026cc2f-5372-4a07-a499-bfa46dc6d3f712014-09-03
43063-401-90EA - Each43063-401ddba0c2d-e69d-4d10-84ff-05d225c6acc512020-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MELOXICAMACTIVE INGREDIENTVG2QF83CGLMELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]7
MELOXICAMACTIVE MOIETYVG2QF83CGLMELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]7
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQMELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]7
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KMELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-401MELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]21Current NDC, Legacy NDC, 6 package rows20250302_1d8b617a-b9b3-473c-be9b-f34a585a1b3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSN1d8b617a-b9b3-473c-be9b-f34a585a1b3b22
152695meloxicam 15 MG Oral TabletSCD1d8b617a-b9b3-473c-be9b-f34a585a1b3b22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-401-06430630401066 TABLET in 1 BOTTLE, PLASTIC (43063-401-06) 6 tablet2012-07-180000-00-00NoNoCurrent
43063-401-144306304011414 TABLET in 1 BOTTLE, PLASTIC (43063-401-14) 14 tablet2020-06-010000-00-00NoNoCurrent
43063-401-154306304011515 TABLET in 1 BOTTLE, PLASTIC (43063-401-15) 15 tablet2012-07-180000-00-00NoNoCurrent
43063-401-284306304012828 TABLET in 1 BOTTLE, PLASTIC (43063-401-28) 28 tablet2019-09-240000-00-00NoNoCurrent
43063-401-304306304013030 TABLET in 1 BOTTLE, PLASTIC (43063-401-30) 30 tablet2012-07-180000-00-00NoNoCurrent
43063-401-604306304016060 TABLET in 1 BOTTLE, PLASTIC (43063-401-60) 60 tablet2012-07-180000-00-00NoNoCurrent
43063-401-904306304019090 TABLET in 1 BOTTLE, PLASTIC (43063-401-90) 90 tablet2012-07-180000-00-00NoNoCurrent