FDA.reportPublic FDA data

Meloxicam

Product NDC
61442-127
11-digit product format
614420127
Labeler code
61442
Product ID
61442-127_34303a6a-f321-bc83-e063-6294a90a4e79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Carlsbad Technology, Inc.
Application
ANDA077918
Marketing category
ANDA
Marketing start
2010-06-30
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, 311486

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61442-127-012023-02-20C16284748780-1f386c64a-1acb-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Meloxicam Tablets, USP safely and effectively. See full prescribing information for Meloxicam Tablets, USP. MELOXICAM Tablets, USP for oral use Initial U.S. Approval: 2000
61442-127-102023-02-20C16284748780-1f386c64a-1acb-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Meloxicam Tablets, USP safely and effectively. See full prescribing information for Meloxicam Tablets, USP. MELOXICAM Tablets, USP for oral use Initial U.S. Approval: 2000
61442-127-302023-02-20C16284748780-1f386c64a-1acb-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Meloxicam Tablets, USP safely and effectively. See full prescribing information for Meloxicam Tablets, USP. MELOXICAM Tablets, USP for oral use Initial U.S. Approval: 2000
61442-127-012023-01-30C16284748780-1f386c64a-1acb-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Meloxicam Tablets, USP safely and effectively. See full prescribing information for Meloxicam Tablets, USP. MELOXICAM Tablets, USP for oral use Initial U.S. Approval: 2000
61442-127-102023-01-30C16284748780-1f386c64a-1acb-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Meloxicam Tablets, USP safely and effectively. See full prescribing information for Meloxicam Tablets, USP. MELOXICAM Tablets, USP for oral use Initial U.S. Approval: 2000
61442-127-302023-01-30C16284748780-1f386c64a-1acb-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Meloxicam Tablets, USP safely and effectively. See full prescribing information for Meloxicam Tablets, USP. MELOXICAM Tablets, USP for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61442-127-01Meloxicam100 in 1 BOTTLE, PLASTICTABLET10017
61442-127-10Meloxicam1000 in 1 BOTTLE, PLASTICTABLET100017
61442-127-30Meloxicam30 in 1 BOTTLE, PLASTICTABLET3017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61442-127-01EA - Each61442-127524b389e-3feb-4fa0-87f1-9083a826d06d12012-07-24
61442-127-10EA - Each61442-1271fa406b3-5839-4cb8-bfcb-18b343de4a9f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MeloxicamACTIVE INGREDIENTVG2QF83CGLMELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]11
MeloxicamACTIVE MOIETYVG2QF83CGLMELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]11
Colloidal Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4MELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]11
LactoseINACTIVE INGREDIENTJ2B2A4N98GMELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]11
Magnesium StearateINACTIVE INGREDIENT70097M6I30MELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]11
Povidone K30INACTIVE INGREDIENTU725QWY32XMELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]11
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRMELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MELOXICAM TABLET [PD-RX PHARMACEUTICALS, INC.]11
MELOXICAMACTIVE INGREDIENTVG2QF83CGLMELOXICAM TABLET [CARLSBAD TECHNOLOGY, INC.]10
MeloxicamACTIVE INGREDIENTVG2QF83CGLMELOXICAM TABLET [READYMEDS]10
MeloxicamACTIVE MOIETYVG2QF83CGLMELOXICAM TABLET [READYMEDS]10
MELOXICAMACTIVE MOIETYVG2QF83CGLMELOXICAM TABLET [CARLSBAD TECHNOLOGY, INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMELOXICAM TABLET [READYMEDS]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMELOXICAM TABLET [CARLSBAD TECHNOLOGY, INC.]10
Colloidal Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4MELOXICAM TABLET [READYMEDS]10
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MELOXICAM TABLET [CARLSBAD TECHNOLOGY, INC.]10
LactoseINACTIVE INGREDIENTJ2B2A4N98GMELOXICAM TABLET [READYMEDS]10
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMELOXICAM TABLET [CARLSBAD TECHNOLOGY, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MELOXICAM TABLET [CARLSBAD TECHNOLOGY, INC.]10
Magnesium StearateINACTIVE INGREDIENT70097M6I30MELOXICAM TABLET [READYMEDS]10
Povidone K30INACTIVE INGREDIENTU725QWY32XMELOXICAM TABLET [READYMEDS]10
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMELOXICAM TABLET [CARLSBAD TECHNOLOGY, INC.]10
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRMELOXICAM TABLET [READYMEDS]10
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRMELOXICAM TABLET [CARLSBAD TECHNOLOGY, INC.]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MELOXICAM TABLET [READYMEDS]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MELOXICAM TABLET [CARLSBAD TECHNOLOGY, INC.]10
MELOXICAMACTIVE INGREDIENTVG2QF83CGLMELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]5
MELOXICAMACTIVE MOIETYVG2QF83CGLMELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]5
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]5
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]5
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]5
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRMELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MELOXICAM TABLET [BLENHEIM PHARMACAL, INC.]5
MeloxicamACTIVE INGREDIENTVG2QF83CGLMELOXICAM (MELOXICAM) TABLET [AVPAK]4
MeloxicamACTIVE MOIETYVG2QF83CGLMELOXICAM (MELOXICAM) TABLET [AVPAK]4
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMELOXICAM (MELOXICAM) TABLET [AVPAK]4
LactoseINACTIVE INGREDIENTJ2B2A4N98GMELOXICAM (MELOXICAM) TABLET [AVPAK]4
Magnesium StearateINACTIVE INGREDIENT70097M6I30MELOXICAM (MELOXICAM) TABLET [AVPAK]4
Povidone K30INACTIVE INGREDIENTU725QWY32XMELOXICAM (MELOXICAM) TABLET [AVPAK]4
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4MELOXICAM (MELOXICAM) TABLET [AVPAK]4
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRMELOXICAM (MELOXICAM) TABLET [AVPAK]4
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2MELOXICAM (MELOXICAM) TABLET [AVPAK]4
MeloxicamACTIVE INGREDIENTVG2QF83CGLMELOXICAM TABLET [DISPENSING SOLUTIONS, INC.]2
MeloxicamACTIVE MOIETYVG2QF83CGLMELOXICAM TABLET [DISPENSING SOLUTIONS, INC.]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMELOXICAM TABLET [DISPENSING SOLUTIONS, INC.]2
LactoseINACTIVE INGREDIENTJ2B2A4N98GMELOXICAM TABLET [DISPENSING SOLUTIONS, INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30MELOXICAM TABLET [DISPENSING SOLUTIONS, INC.]2
Povidone K30INACTIVE INGREDIENTU725QWY32XMELOXICAM TABLET [DISPENSING SOLUTIONS, INC.]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4MELOXICAM TABLET [DISPENSING SOLUTIONS, INC.]2
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRMELOXICAM TABLET [DISPENSING SOLUTIONS, INC.]2
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2MELOXICAM TABLET [DISPENSING SOLUTIONS, INC.]2
MELOXICAMACTIVE INGREDIENTVG2QF83CGLMELOXICAM TABLET [MEDSOURCE PHARMACEUTICALS]1
MELOXICAMACTIVE MOIETYVG2QF83CGLMELOXICAM TABLET [MEDSOURCE PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMELOXICAM TABLET [MEDSOURCE PHARMACEUTICALS]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMELOXICAM TABLET [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MELOXICAM TABLET [MEDSOURCE PHARMACEUTICALS]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMELOXICAM TABLET [MEDSOURCE PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MELOXICAM TABLET [MEDSOURCE PHARMACEUTICALS]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRMELOXICAM TABLET [MEDSOURCE PHARMACEUTICALS]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MELOXICAM TABLET [MEDSOURCE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61442-127MELOXICAM TABLET [CARLSBAD TECHNOLOGY, INC.]16Current NDC, Legacy NDC, 3 package rows20250112_20871c7f-1e36-49ef-8e2b-70112430ca1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSN218e71c6-265a-45f4-b660-5c1da5a36bd2103
152695meloxicam 15 MG Oral TabletSCD218e71c6-265a-45f4-b660-5c1da5a36bd2103
152695meloxicam 15 MG Oral TabletPSNed9c8c21-1d08-4afa-9cd2-3fd8b2a83baf102
152695meloxicam 15 MG Oral TabletSCDed9c8c21-1d08-4afa-9cd2-3fd8b2a83baf102
152695meloxicam 15 MG Oral TabletPSNd3182622-4b9b-4850-bf9f-108c5610eb40101
152695meloxicam 15 MG Oral TabletSCDd3182622-4b9b-4850-bf9f-108c5610eb40101
152695meloxicam 15 MG Oral TabletPSNeae60d2c-411c-460a-b673-05b5784ed94332
152695meloxicam 15 MG Oral TabletSCDeae60d2c-411c-460a-b673-05b5784ed94332
152695meloxicam 15 MG Oral TabletPSN20871c7f-1e36-49ef-8e2b-70112430ca1e17
311486meloxicam 7.5 MG Oral TabletPSN20871c7f-1e36-49ef-8e2b-70112430ca1e17
152695meloxicam 15 MG Oral TabletSCD20871c7f-1e36-49ef-8e2b-70112430ca1e17
311486meloxicam 7.5 MG Oral TabletSCD20871c7f-1e36-49ef-8e2b-70112430ca1e17
152695meloxicam 15 MG Oral TabletPSNee8df8fa-d08a-8c8b-f048-813e5022a10110
152695meloxicam 15 MG Oral TabletPSN8b2aa351-4ac3-4b5f-a20c-060805812cd010
311486meloxicam 7.5 MG Oral TabletPSNee8df8fa-d08a-8c8b-f048-813e5022a10110
311486meloxicam 7.5 MG Oral TabletPSN8b2aa351-4ac3-4b5f-a20c-060805812cd010
152695meloxicam 15 MG Oral TabletSCDee8df8fa-d08a-8c8b-f048-813e5022a10110
152695meloxicam 15 MG Oral TabletSCD8b2aa351-4ac3-4b5f-a20c-060805812cd010
311486meloxicam 7.5 MG Oral TabletSCDee8df8fa-d08a-8c8b-f048-813e5022a10110
311486meloxicam 7.5 MG Oral TabletSCD8b2aa351-4ac3-4b5f-a20c-060805812cd010
152695meloxicam 15 MG Oral TabletPSN55a30270-6082-452b-a081-657d51378e845
152695meloxicam 15 MG Oral TabletPSNd27feaf7-731e-1a8f-e053-2a95a90afa715
311486meloxicam 7.5 MG Oral TabletPSNd27feaf7-731e-1a8f-e053-2a95a90afa715
152695meloxicam 15 MG Oral TabletSCD55a30270-6082-452b-a081-657d51378e845
152695meloxicam 15 MG Oral TabletSCDd27feaf7-731e-1a8f-e053-2a95a90afa715
311486meloxicam 7.5 MG Oral TabletSCDd27feaf7-731e-1a8f-e053-2a95a90afa715
152695meloxicam 15 MG Oral TabletPSN2a29daa9-74e5-4ed6-b5f1-ce04dc411b262
152695meloxicam 15 MG Oral TabletPSN8685a269-d533-4970-889e-d70e8b958ccd2
152695meloxicam 15 MG Oral TabletPSNb5d72a30-3d32-45ad-be81-3fe601d8912b2
311486meloxicam 7.5 MG Oral TabletPSNb5d72a30-3d32-45ad-be81-3fe601d8912b2
152695meloxicam 15 MG Oral TabletSCD8685a269-d533-4970-889e-d70e8b958ccd2
152695meloxicam 15 MG Oral TabletSCD2a29daa9-74e5-4ed6-b5f1-ce04dc411b262
152695meloxicam 15 MG Oral TabletSCDb5d72a30-3d32-45ad-be81-3fe601d8912b2
311486meloxicam 7.5 MG Oral TabletSCDb5d72a30-3d32-45ad-be81-3fe601d8912b2
152695meloxicam 15 MG Oral TabletPSN2adb9f9b-c49c-4137-9e2e-8be9065639e61
152695meloxicam 15 MG Oral TabletSCD2adb9f9b-c49c-4137-9e2e-8be9065639e61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61442-127-0161442012701100 TABLET in 1 BOTTLE, PLASTIC (61442-127-01) 100 tablet2010-06-300000-00-00NoNoCurrent
61442-127-10614420127101000 TABLET in 1 BOTTLE, PLASTIC (61442-127-10) 1000 tablet2010-06-300000-00-00NoNoCurrent
61442-127-306144201273030 TABLET in 1 BOTTLE, PLASTIC (61442-127-30) 30 tablet2010-06-300000-00-00NoNoCurrent