Meloxicam

Product NDC
66116-393
11-digit product format
661160393
Labeler code
66116
Product ID
66116-393_f6bf82d1-b768-49de-bc6c-1078dfc3c359
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
MedVantx, Inc.
Application
ANDA078008
Marketing category
ANDA
Marketing start
2006-10-02
Marketing end
0000-00-00
Substance
MELOXICAM
Active strength
15 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66116-393IInactivated by FDA2026-08-03
excluded packagepackage66116-39366116-393-30IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66116-393-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66116-393-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66116-393-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66116-393-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66116-393-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66116-393-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66116-393-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66116-393-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66116-393-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66116-393-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66116-393-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66116-393-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66116-393-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66116-393-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66116-393-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66116-393-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66116-393-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66116-393-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66116-393-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66116-393-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage66116-393-309bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage66116-393-30110d247fa046…a55b01930146…

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
A078008-001MELOXICAMMELOXICAM7.5MGTABLET / ORALAB2006-10-02
A078008-002MELOXICAMMELOXICAM15MGTABLET / ORALAB2006-10-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078008-001AB
A078008-002AB

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 UTC2026-02A078008-001MELOXICAM7.5MGTABLET / ORALAB2006-10-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078008-002MELOXICAM15MGTABLET / ORALAB2006-10-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078008-001MELOXICAM7.5MGTABLET / ORALAB2006-10-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078008-002MELOXICAM15MGTABLET / ORALAB2006-10-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A078008-001MELOXICAM7.5MGTABLET / ORALAB2006-10-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078008-002MELOXICAM15MGTABLET / ORALAB2006-10-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078008-001MELOXICAM7.5MGTABLET / ORALAB2006-10-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078008-002MELOXICAM15MGTABLET / ORALAB2006-10-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078008-001MELOXICAM7.5MGTABLET / ORALAB2006-10-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078008-002MELOXICAM15MGTABLET / ORALAB2006-10-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078008-001MELOXICAM7.5MGTABLET / ORALAB2006-10-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078008-002MELOXICAM15MGTABLET / ORALAB2006-10-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078008-001MELOXICAM7.5MGTABLET / ORALAB2006-10-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078008-002MELOXICAM15MGTABLET / ORALAB2006-10-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078008-001MELOXICAM7.5MGTABLET / ORALAB2006-10-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078008-002MELOXICAM15MGTABLET / ORALAB2006-10-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078008-001MELOXICAM7.5MGTABLET / ORALAB2006-10-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078008-002MELOXICAM15MGTABLET / ORALAB2006-10-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078008-001MELOXICAM7.5MGTABLET / ORALAB2006-10-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A078008-002MELOXICAM15MGTABLET / ORALAB2006-10-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078008-001MELOXICAM7.5MGTABLET / ORALAB2006-10-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078008-002MELOXICAM15MGTABLET / ORALAB2006-10-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078008-001MELOXICAM7.5MGTABLET / ORALAB2006-10-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078008-002MELOXICAM15MGTABLET / ORALAB2006-10-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078008-001MELOXICAM7.5MGTABLET / ORALAB2006-10-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078008-002MELOXICAM15MGTABLET / ORALAB2006-10-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078008-001MELOXICAM7.5MGTABLET / ORALAB2006-10-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078008-002MELOXICAM15MGTABLET / ORALAB2006-10-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078008-001MELOXICAM7.5MGTABLET / ORALAB2006-10-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078008-002MELOXICAM15MGTABLET / ORALAB2006-10-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078008-001MELOXICAM7.5MGTABLET / ORALAB2006-10-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078008-002MELOXICAM15MGTABLET / ORALAB2006-10-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078008-001MELOXICAM7.5MGTABLET / ORALAB2006-10-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078008-002MELOXICAM15MGTABLET / ORALAB2006-10-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078008-001MELOXICAM7.5MGTABLET / ORALAB2006-10-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078008-002MELOXICAM15MGTABLET / ORALAB2006-10-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078008-001MELOXICAM7.5MGTABLET / ORALAB2006-10-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078008-002MELOXICAM15MGTABLET / ORALAB2006-10-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078008-001MELOXICAM7.5MGTABLET / ORALAB2006-10-02782e0a99824c…
2021-12-28 21:50 UTC2021-12A078008-002MELOXICAM15MGTABLET / ORALAB2006-10-02782e0a99824c…

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 UTC2026-02A078008-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078008-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078008-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078008-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078008-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078008-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078008-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078008-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078008-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078008-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078008-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078008-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078008-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078008-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078008-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078008-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078008-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078008-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078008-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078008-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078008-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078008-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078008-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078008-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078008-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078008-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078008-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078008-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078008-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078008-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078008-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078008-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078008-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078008-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078008-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078008-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078008-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078008-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078008-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078008-002AB1782e0a99824c…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66116-393-30Meloxicam30 in 1 BOTTLETABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MELOXICAMACTIVE INGREDIENTVG2QF83CGLMELOXICAM TABLET [MEDVANTX, INC.]1
MELOXICAMACTIVE MOIETYVG2QF83CGLMELOXICAM TABLET [MEDVANTX, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMELOXICAM TABLET [MEDVANTX, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMELOXICAM TABLET [MEDVANTX, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMELOXICAM TABLET [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MELOXICAM TABLET [MEDVANTX, INC.]1
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35MELOXICAM TABLET [MEDVANTX, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MELOXICAM TABLET [MEDVANTX, INC.]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KMELOXICAM TABLET [MEDVANTX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66116-393MELOXICAM TABLET [MEDVANTX, INC.]1Legacy NDC, 1 package rows20130823_f6bf82d1-b768-49de-bc6c-1078dfc3c359.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MeloxicamMELOXICAMAurobindo Pharma Limitedd5e12448-1ca1-46a4-8de4-e8b94567e5a82025-03-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078008
application number: ANDA078008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSNf6bf82d1-b768-49de-bc6c-1078dfc3c3591
152695meloxicam 15 MG Oral TabletSCDf6bf82d1-b768-49de-bc6c-1078dfc3c3591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66116-393-306611603933030 in 1 BOTTLEHistorical