FDA.reportPublic FDA data

Meloxicam

Product NDC
53225-3075
11-digit product format
532253075
Labeler code
53225
Product ID
53225-3075_42f45cbf-49c5-8971-e063-6394a90a291d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Terrain Pharmaceuticals, Inc.
Application
ANDA077882
Marketing category
ANDA
Marketing start
2025-10-20
Substance
MELOXICAM
Active strength
7.5 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077882-001MELOXICAMMELOXICAM7.5MGTABLET / ORALAB2006-07-20
A077882-002MELOXICAMMELOXICAM15MGTABLET / ORALAB2006-07-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A077882-001AB
A077882-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077882-001MELOXICAM7.5MGTABLET / ORALAB2006-07-20a50c72e98297…
2026-08-01 22:54:322026-06A077882-002MELOXICAM15MGTABLET / ORALAB2006-07-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077882-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077882-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MeloxicamMELOXICAMAdvanced Rx of Tennessee, LLC5488ccc1-e416-e5d7-e063-6294a90a6cb82026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077882
application number: ANDA077882
MeloxicamMELOXICAMAdvanced Rx of Tennessee, LLC548ec3b7-2b6d-cd9e-e063-6394a90a78ff2026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077882
application number: ANDA077882
MeloxicamMELOXICAMAdvanced Rx of Tennessee, LLC548ef3ed-ab67-ec85-e063-6294a90ab1da2026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077882
application number: ANDA077882
MeloxicamMELOXICAMTerrain Pharmaceuticals, Inc.b603255e-1fcf-42ec-ab62-9aa321cb7ac62026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077882
application number: ANDA077882
ndc (product): 53225-3075
MeloxicamMELOXICAMBryant Ranch Prepack7895f389-1509-4e03-8668-526ab1627fc82026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077882
application number: ANDA077882
MeloxicamMELOXICAMAdvanced Rx of Tennessee, LLC445d7cbf-bd3e-a54f-e063-6294a90a67a52025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077882
application number: ANDA077882
MeloxicamMELOXICAMAdvanced Rx of Tennessee, LLC445dc4f6-daac-e2f1-e063-6394a90a0ca52025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077882
application number: ANDA077882
MeloxicamMELOXICAMAdvanced Rx of Tennessee, LLC453c5328-090e-0159-e063-6394a90a06b72025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077882
application number: ANDA077882

Additional Listing Data#

Finished product
Yes
Brand name base
Meloxicam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MELOXICAM7.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VG2QF83CGLInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
152695Internal RxNorm lookup
311486Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b603255e-1fcf-42ec-ab62-9aa321cb7ac6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bdef11ce-16e2-4690-96a3-597bcf5cc738Product name120260130
f2791553-0b76-42f4-8d49-af3eda072bfbProduct name120251117
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
3e9b4ed6-844c-4725-9d19-cceb5c823572Product name220210903
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
b21a682e-c765-4e26-9bb2-dbb8c7b38ef7Product name120200623
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
a428d1db-64d7-4fc3-8d13-832b1e84b683Product name120190201
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
96649a58-aac8-401c-be00-450b4335f7e7Product name120161116
f0761cb7-8207-3a19-2ca3-ecbb559b04e1Product name220161116
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53225-3075-1Meloxicam30 in 1 BOTTLETABLET302
53225-3075-2Meloxicam60 in 1 BOTTLETABLET602
53225-3075-3Meloxicam90 in 1 BOTTLETABLET902
53225-3075-4Meloxicam100 in 1 BOTTLETABLET1002
53225-3075-5Meloxicam120 in 1 BOTTLETABLET1202
53225-3075-6Meloxicam500 in 1 BOTTLETABLET5002
53225-3075-7Meloxicam1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53225-3075-1EA - Each53225-30759f34ef86-c2f9-453c-91e5-0750acf4303f12026-01-08
53225-3075-2EA - Each53225-30755741ecf4-ea23-4687-8de0-2269971bc93512026-01-08
53225-3075-3EA - Each53225-3075a1a9b350-85db-4c79-9425-4f6f48d0a8b912026-01-08
53225-3075-4EA - Each53225-3075ad0b0d72-8db3-4dc6-9831-b41644cfa20312026-01-08
53225-3075-5EA - Each53225-3075b26a7365-1b95-4588-912b-b03b7635499112026-01-08
53225-3075-6EA - Each53225-3075d8c17720-2c29-48fc-9a47-8eeb4dbd002912026-01-08
53225-3075-7EA - Each53225-3075163c63ea-c314-47dd-a560-30eacc5cf43812026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSNb603255e-1fcf-42ec-ab62-9aa321cb7ac62
311486meloxicam 7.5 MG Oral TabletPSN445d7cbf-bd3e-a54f-e063-6294a90a67a52
311486meloxicam 7.5 MG Oral TabletPSN445dc4f6-daac-e2f1-e063-6394a90a0ca52
311486meloxicam 7.5 MG Oral TabletPSNb603255e-1fcf-42ec-ab62-9aa321cb7ac62
152695meloxicam 15 MG Oral TabletSCDb603255e-1fcf-42ec-ab62-9aa321cb7ac62
311486meloxicam 7.5 MG Oral TabletSCD445d7cbf-bd3e-a54f-e063-6294a90a67a52
311486meloxicam 7.5 MG Oral TabletSCD445dc4f6-daac-e2f1-e063-6394a90a0ca52
311486meloxicam 7.5 MG Oral TabletSCDb603255e-1fcf-42ec-ab62-9aa321cb7ac62
311486meloxicam 7.5 MG Oral TabletPSN453c5328-090e-0159-e063-6394a90a06b71
311486meloxicam 7.5 MG Oral TabletPSN7895f389-1509-4e03-8668-526ab1627fc81
311486meloxicam 7.5 MG Oral TabletSCD453c5328-090e-0159-e063-6394a90a06b71
311486meloxicam 7.5 MG Oral TabletSCD7895f389-1509-4e03-8668-526ab1627fc81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53225-3075-15322530750130 TABLET in 1 BOTTLE (53225-3075-1) 30 tablet2025-10-20NoNoCurrent
53225-3075-25322530750260 TABLET in 1 BOTTLE (53225-3075-2) 60 tablet2025-10-20NoNoCurrent
53225-3075-35322530750390 TABLET in 1 BOTTLE (53225-3075-3) 90 tablet2025-10-20NoNoCurrent
53225-3075-453225307504100 TABLET in 1 BOTTLE (53225-3075-4) 100 tablet2025-10-20NoNoCurrent
53225-3075-553225307505120 TABLET in 1 BOTTLE (53225-3075-5) 120 tablet2025-10-20NoNoCurrent
53225-3075-653225307506500 TABLET in 1 BOTTLE (53225-3075-6) 500 tablet2025-10-20NoNoCurrent
53225-3075-7532253075071000 TABLET in 1 BOTTLE (53225-3075-7) 1000 tablet2025-10-20NoNoCurrent