Meloxicam

Product NDC
70934-297
Requested package NDC
70934-297-90
11-digit product format
709340297
Labeler code
70934
Product ID
70934-297_a5654132-ca5e-f592-e053-2a95a90a69eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA077918
Marketing category
ANDA
Marketing start
2019-02-26
Marketing end
0000-00-00
Substance
MELOXICAM
Active strength
8 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
2021-12-31
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 packagepackage70934-29770934-297-90DDiscontinued by firm2026-08-07

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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…

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
A077918-001MELOXICAMMELOXICAM7.5MGTABLET / ORALAB2006-12-07
A077918-002MELOXICAMMELOXICAM15MGTABLET / ORALAB2006-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077918-001AB
A077918-002AB

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 UTC2026-02A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077918-001MELOXICAM7.5MGTABLET / ORALAB2006-12-07782e0a99824c…
2021-12-28 21:50 UTC2021-12A077918-002MELOXICAM15MGTABLET / ORALAB2006-12-07782e0a99824c…

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 UTC2026-02A077918-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077918-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077918-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077918-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077918-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077918-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077918-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077918-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077918-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077918-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077918-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077918-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077918-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077918-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077918-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077918-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077918-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077918-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077918-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077918-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077918-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077918-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077918-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077918-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077918-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077918-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077918-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077918-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077918-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077918-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077918-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077918-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077918-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077918-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077918-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077918-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077918-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077918-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077918-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077918-002AB1782e0a99824c…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
70934-297-302023-02-01These 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
70934-297-602023-02-01These 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
70934-297-902023-02-01These 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
70934-297-302022-01-28These 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
70934-297-602022-01-28These 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
70934-297-902022-01-28These 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-297-30EA - Each70934-297b0fe65c0-e9ec-4f23-b1c8-0cea4edaffd912022-02-07
70934-297-90EA - Each70934-29770d12302-3881-47c4-b126-0ae49ec9952312022-12-07

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MeloxicamMELOXICAMPD-Rx Pharmaceuticals, Inc.1ab45be4-b2b9-4374-95ab-620e0f90fb702026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
MeloxicamMELOXICAMPD-Rx Pharmaceuticals, Inc.eae60d2c-411c-460a-b673-05b5784ed9432026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
MeloxicamMELOXICAMGolden State Medical Supply, Inc.d27feaf7-731e-1a8f-e053-2a95a90afa712026-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
MeloxicamMELOXICAMAvPAKee8df8fa-d08a-8c8b-f048-813e5022a1012025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
MeloxicamMELOXICAMCarlsbad Technology, Inc.20871c7f-1e36-49ef-8e2b-70112430ca1e2025-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
MeloxicamMELOXICAMBryant Ranch Prepackd3182622-4b9b-4850-bf9f-108c5610eb402025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
MeloxicamMELOXICAMBryant Ranch Prepacked9c8c21-1d08-4afa-9cd2-3fd8b2a83baf2025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
MeloxicamMELOXICAMBryant Ranch Prepack75af3e09-f510-45a4-9f21-50bff7aa55102025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
MeloxicamMELOXICAMBryant Ranch Prepack218e71c6-265a-45f4-b660-5c1da5a36bd22025-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
MeloxicamMELOXICAMAphena Pharma Solutions - Tennessee, LLCe1603665-bbce-48b3-9424-3646570ae9b82022-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
MeloxicamMELOXICAMProficient Rx LPb5d72a30-3d32-45ad-be81-3fe601d8912b2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
MeloxicamMELOXICAMAphena Pharma Solutions - Tennessee, LLC8f43b954-d1cb-4210-b479-5292c446cc742021-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918
MeloxicamMELOXICAMAphena Pharma Solutions - Tennessee, LLC2a29daa9-74e5-4ed6-b5f1-ce04dc411b262020-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077918
application number: ANDA077918

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-297-907093402979090 TABLET in 1 BOTTLE, PLASTIC (70934-297-90) 90 tablet2020-04-280000-00-00NoNoCurrent