Meloxicam

Product NDC
64380-716
Requested package NDC
64380-716-06
11-digit product format
643800716
Labeler code
64380
Product ID
64380-716_267a3598-712e-4f02-a78f-78cff4ac4ab7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA077928
Marketing category
ANDA
Marketing start
2009-05-14
Marketing end
0000-00-00
Substance
MELOXICAM
Active strength
15 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage64380-71664380-716-06DDiscontinued by firm2026-10-05

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64380-71664380-716-06DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64380-71664380-716-06DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077928-001MELOXICAMMELOXICAM7.5MGTABLET / ORALAB2009-05-13
A077928-002MELOXICAMMELOXICAM15MGTABLET / ORALAB2009-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077928-001AB
A077928-002AB

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077928-001MELOXICAM7.5MGTABLET / ORALAB2009-05-1384e616aacf4f…
2026-09-14 22:38:342026-08A077928-002MELOXICAM15MGTABLET / ORALAB2009-05-1384e616aacf4f…
2026-08-18 06:07:402026-07A077928-001MELOXICAM7.5MGTABLET / ORALAB2009-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07A077928-002MELOXICAM15MGTABLET / ORALAB2009-05-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077928-001MELOXICAM7.5MGTABLET / ORALAB2009-05-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077928-002MELOXICAM15MGTABLET / ORALAB2009-05-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077928-001MELOXICAM7.5MGTABLET / ORALAB2009-05-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077928-002MELOXICAM15MGTABLET / ORALAB2009-05-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077928-001MELOXICAM7.5MGTABLET / ORALAB2009-05-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077928-002MELOXICAM15MGTABLET / ORALAB2009-05-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077928-001MELOXICAM7.5MGTABLET / ORALAB2009-05-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077928-002MELOXICAM15MGTABLET / ORALAB2009-05-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077928-001MELOXICAM7.5MGTABLET / ORALAB2009-05-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077928-002MELOXICAM15MGTABLET / ORALAB2009-05-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077928-001MELOXICAM7.5MGTABLET / ORALAB2009-05-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077928-002MELOXICAM15MGTABLET / ORALAB2009-05-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077928-001MELOXICAM7.5MGTABLET / ORALAB2009-05-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077928-002MELOXICAM15MGTABLET / ORALAB2009-05-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077928-001MELOXICAM7.5MGTABLET / ORALAB2009-05-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077928-002MELOXICAM15MGTABLET / ORALAB2009-05-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077928-001MELOXICAM7.5MGTABLET / ORALAB2009-05-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077928-002MELOXICAM15MGTABLET / ORALAB2009-05-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077928-001MELOXICAM7.5MGTABLET / ORALAB2009-05-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A077928-002MELOXICAM15MGTABLET / ORALAB2009-05-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077928-001MELOXICAM7.5MGTABLET / ORALAB2009-05-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077928-002MELOXICAM15MGTABLET / ORALAB2009-05-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077928-001MELOXICAM7.5MGTABLET / ORALAB2009-05-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077928-002MELOXICAM15MGTABLET / ORALAB2009-05-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077928-001MELOXICAM7.5MGTABLET / ORALAB2009-05-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077928-002MELOXICAM15MGTABLET / ORALAB2009-05-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077928-001MELOXICAM7.5MGTABLET / ORALAB2009-05-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077928-002MELOXICAM15MGTABLET / ORALAB2009-05-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077928-001MELOXICAM7.5MGTABLET / ORALAB2009-05-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077928-002MELOXICAM15MGTABLET / ORALAB2009-05-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077928-001MELOXICAM7.5MGTABLET / ORALAB2009-05-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077928-002MELOXICAM15MGTABLET / ORALAB2009-05-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077928-001MELOXICAM7.5MGTABLET / ORALAB2009-05-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077928-002MELOXICAM15MGTABLET / ORALAB2009-05-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077928-001MELOXICAM7.5MGTABLET / ORALAB2009-05-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077928-002MELOXICAM15MGTABLET / ORALAB2009-05-1374a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077928-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077928-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A077928-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077928-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077928-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077928-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077928-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077928-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077928-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077928-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077928-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077928-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077928-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077928-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077928-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077928-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077928-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077928-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077928-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077928-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077928-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077928-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077928-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077928-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077928-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077928-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077928-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077928-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077928-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077928-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077928-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077928-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077928-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077928-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077928-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077928-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077928-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077928-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077928-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077928-002AB174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MELOXICAMACTIVE INGREDIENTVG2QF83CGLMELOXICAM TABLET [STRIDES ARCOLAB LIMITED]1
MELOXICAMACTIVE MOIETYVG2QF83CGLMELOXICAM TABLET [STRIDES ARCOLAB LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMELOXICAM TABLET [STRIDES ARCOLAB LIMITED]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMELOXICAM TABLET [STRIDES ARCOLAB LIMITED]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMELOXICAM TABLET [STRIDES ARCOLAB LIMITED]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMELOXICAM TABLET [STRIDES ARCOLAB LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MELOXICAM TABLET [STRIDES ARCOLAB LIMITED]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMELOXICAM TABLET [STRIDES ARCOLAB LIMITED]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRMELOXICAM TABLET [STRIDES ARCOLAB LIMITED]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-716-0664380071606100 TABLET in 1 BOTTLE (64380-716-06) 100 tablet2009-05-140000-00-00NoNoCurrent