Meloxicam

Product NDC
53225-3075
Requested package NDC
53225-3075-1
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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077882-001MELOXICAM7.5MGTABLET / ORALAB2006-07-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077882-002MELOXICAM15MGTABLET / ORALAB2006-07-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077882-001MELOXICAM7.5MGTABLET / ORALAB2006-07-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077882-002MELOXICAM15MGTABLET / ORALAB2006-07-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077882-001MELOXICAM7.5MGTABLET / ORALAB2006-07-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077882-002MELOXICAM15MGTABLET / ORALAB2006-07-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077882-001MELOXICAM7.5MGTABLET / ORALAB2006-07-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077882-002MELOXICAM15MGTABLET / ORALAB2006-07-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077882-001MELOXICAM7.5MGTABLET / ORALAB2006-07-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077882-002MELOXICAM15MGTABLET / ORALAB2006-07-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077882-001MELOXICAM7.5MGTABLET / ORALAB2006-07-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077882-002MELOXICAM15MGTABLET / ORALAB2006-07-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077882-001MELOXICAM7.5MGTABLET / ORALAB2006-07-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077882-002MELOXICAM15MGTABLET / ORALAB2006-07-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077882-001MELOXICAM7.5MGTABLET / ORALAB2006-07-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077882-002MELOXICAM15MGTABLET / ORALAB2006-07-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077882-001MELOXICAM7.5MGTABLET / ORALAB2006-07-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077882-002MELOXICAM15MGTABLET / ORALAB2006-07-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077882-001MELOXICAM7.5MGTABLET / ORALAB2006-07-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A077882-002MELOXICAM15MGTABLET / ORALAB2006-07-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077882-001MELOXICAM7.5MGTABLET / ORALAB2006-07-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077882-002MELOXICAM15MGTABLET / ORALAB2006-07-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077882-001MELOXICAM7.5MGTABLET / ORALAB2006-07-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077882-002MELOXICAM15MGTABLET / ORALAB2006-07-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077882-001MELOXICAM7.5MGTABLET / ORALAB2006-07-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077882-002MELOXICAM15MGTABLET / ORALAB2006-07-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077882-001MELOXICAM7.5MGTABLET / ORALAB2006-07-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077882-002MELOXICAM15MGTABLET / ORALAB2006-07-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077882-001MELOXICAM7.5MGTABLET / ORALAB2006-07-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077882-002MELOXICAM15MGTABLET / ORALAB2006-07-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077882-001MELOXICAM7.5MGTABLET / ORALAB2006-07-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077882-002MELOXICAM15MGTABLET / ORALAB2006-07-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077882-001MELOXICAM7.5MGTABLET / ORALAB2006-07-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077882-002MELOXICAM15MGTABLET / ORALAB2006-07-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077882-001MELOXICAM7.5MGTABLET / ORALAB2006-07-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077882-002MELOXICAM15MGTABLET / ORALAB2006-07-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077882-001MELOXICAM7.5MGTABLET / ORALAB2006-07-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077882-002MELOXICAM15MGTABLET / ORALAB2006-07-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077882-001MELOXICAM7.5MGTABLET / ORALAB2006-07-20782e0a99824c…
2021-12-28 21:50 UTC2021-12A077882-002MELOXICAM15MGTABLET / ORALAB2006-07-20782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077882-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077882-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077882-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077882-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077882-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077882-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077882-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077882-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077882-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077882-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077882-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077882-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077882-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077882-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077882-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077882-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077882-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077882-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077882-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077882-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077882-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077882-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077882-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077882-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077882-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077882-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077882-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077882-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077882-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077882-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077882-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077882-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077882-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077882-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077882-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077882-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077882-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077882-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077882-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077882-002AB1782e0a99824c…

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 (package): 53225-3075-1
ndc (product): 53225-3075
ndc11 (package): 53225307501
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

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