Meloxicam

Product NDC
80425-0043
11-digit product format
804250043
Labeler code
80425
Product ID
80425-0043_2a989dd1-65ca-966d-e063-6294a90ae8ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA077929
Marketing category
ANDA
Marketing start
2006-07-19
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
A077929-001MELOXICAMMELOXICAM7.5MGTABLET / ORALAB2006-07-19
A077929-002MELOXICAMMELOXICAM15MGTABLET / ORALAB2006-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077929-001AB
A077929-002AB

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 UTC2026-02A077929-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077929-002MELOXICAM15MGTABLET / ORALAB2006-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077929-001MELOXICAM7.5MGTABLET / ORALAB2006-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077929-002MELOXICAM15MGTABLET / ORALAB2006-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077929-001MELOXICAM7.5MGTABLET / ORALAB2006-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077929-002MELOXICAM15MGTABLET / ORALAB2006-07-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077929-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077929-002MELOXICAM15MGTABLET / ORALAB2006-07-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077929-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077929-002MELOXICAM15MGTABLET / ORALAB2006-07-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077929-001MELOXICAM7.5MGTABLET / ORALAB2006-07-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077929-002MELOXICAM15MGTABLET / ORALAB2006-07-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077929-001MELOXICAM7.5MGTABLET / ORALAB2006-07-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077929-002MELOXICAM15MGTABLET / ORALAB2006-07-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077929-001MELOXICAM7.5MGTABLET / ORALAB2006-07-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077929-002MELOXICAM15MGTABLET / ORALAB2006-07-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077929-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077929-002MELOXICAM15MGTABLET / ORALAB2006-07-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077929-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A077929-002MELOXICAM15MGTABLET / ORALAB2006-07-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077929-001MELOXICAM7.5MGTABLET / ORALAB2006-07-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077929-002MELOXICAM15MGTABLET / ORALAB2006-07-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077929-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077929-002MELOXICAM15MGTABLET / ORALAB2006-07-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077929-001MELOXICAM7.5MGTABLET / ORALAB2006-07-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077929-002MELOXICAM15MGTABLET / ORALAB2006-07-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077929-001MELOXICAM7.5MGTABLET / ORALAB2006-07-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077929-002MELOXICAM15MGTABLET / ORALAB2006-07-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077929-001MELOXICAM7.5MGTABLET / ORALAB2006-07-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077929-002MELOXICAM15MGTABLET / ORALAB2006-07-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077929-001MELOXICAM7.5MGTABLET / ORALAB2006-07-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077929-002MELOXICAM15MGTABLET / ORALAB2006-07-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077929-001MELOXICAM7.5MGTABLET / ORALAB2006-07-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077929-002MELOXICAM15MGTABLET / ORALAB2006-07-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077929-001MELOXICAM7.5MGTABLET / ORALAB2006-07-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077929-002MELOXICAM15MGTABLET / ORALAB2006-07-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077929-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077929-002MELOXICAM15MGTABLET / ORALAB2006-07-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077929-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19782e0a99824c…
2021-12-28 21:50 UTC2021-12A077929-002MELOXICAM15MGTABLET / ORALAB2006-07-19782e0a99824c…

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 UTC2026-02A077929-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077929-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077929-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077929-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077929-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077929-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077929-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077929-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077929-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077929-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077929-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077929-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077929-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077929-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077929-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077929-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077929-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077929-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077929-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077929-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077929-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077929-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077929-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077929-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077929-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077929-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077929-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077929-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077929-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077929-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077929-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077929-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077929-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077929-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077929-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077929-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077929-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077929-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077929-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077929-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Meloxicam
Listing expiration
2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
af9d0426-9cbb-a6a3-e053-2995a90aed2fAvailable 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0043-1Meloxicam30 in 1 BOTTLETABLET307
80425-0043-2Meloxicam60 in 1 BOTTLETABLET607
80425-0043-3Meloxicam90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0043-1EA - Each80425-00439d76d3f2-1e21-4c6d-8ca3-c5bcc495871b12023-04-07
80425-0043-2EA - Each80425-0043b0bc572e-d0a9-4497-a3e6-5725fc4c693012023-04-07
80425-0043-3EA - Each80425-00432b6311c8-0f3c-4548-8e8f-676fe23c4fc212023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0043MELOXICAM TABLET [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 3 package rows20250101_af9d0426-9cbb-a6a3-e053-2995a90aed2f.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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MELOXICAMMELOXICAMREMEDYREPACK INC.f8c35ea4-d6ac-40c7-8f35-864fd1ec75d22026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077929
application number: ANDA077929
MELOXICAMMELOXICAMREMEDYREPACK INC.385b7cf4-976a-4a58-9ebc-def8b6e78b752026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077929
application number: ANDA077929
MELOXICAMMELOXICAMREMEDYREPACK INC.cdd282df-572f-42a7-a1c6-a00e1bb4573d2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077929
application number: ANDA077929
MELOXICAMMELOXICAMRedpharm Drug5407aded-9f84-72ce-e063-6394a90ae6722026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077929
application number: ANDA077929
MELOXICAMMELOXICAMSt. Mary's Medical Park Pharmacyfbe71312-0f9d-47c1-e053-6394a90a63a12026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077929
application number: ANDA077929
MELOXICAMMELOXICAMA-S Medication Solutionsfe41eca5-33f1-4ded-a177-d8f927f3f2612026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077929
application number: ANDA077929
MELOXICAMMELOXICAMA-S Medication Solutions2cc0c4c2-eac9-4820-942a-6c606dfb4aa12026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077929
application number: ANDA077929
MELOXICAMMELOXICAMA-S Medication Solutions7a4212a8-7761-4a77-aa18-ecf1f1244df22026-02-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077929
application number: ANDA077929
MELOXICAMMELOXICAMA-S Medication Solutionscdb998b4-093f-45de-90eb-a3dc03dbfd1e2026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077929
application number: ANDA077929
MELOXICAMMELOXICAMNorthwind Health Company, LLCf2b42bdc-47e1-19c5-e053-2a95a90a18282026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077929
application number: ANDA077929
MELOXICAMMELOXICAMNorthwind Health Company, LLCf31d181a-33cb-560f-e053-2995a90abbd92026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077929
application number: ANDA077929
MELOXICAMMELOXICAMCipla USA Inc.bb83cd61-0a82-4fe0-b72e-5b715cbd656d2025-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077929
application number: ANDA077929
MELOXICAMMELOXICAMPHOENIX RX LLC3b1938e5-7a9e-b214-e063-6394a90a12702025-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077929
application number: ANDA077929
MELOXICAMMELOXICAMAsclemed USA, Inc.6d7ede5a-c12e-4979-a47a-f3346ea5bc802025-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077929
application number: ANDA077929
MeloxicamMELOXICAMAdvanced Rx of Tennessee, LLCaf9d0426-9cbb-a6a3-e053-2995a90aed2f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077929
application number: ANDA077929
ndc (product): 80425-0043
MeloxicamMELOXICAMAdvanced Rx of Tennessee, LLCb33bf17a-3134-6f32-e053-2a95a90a261b2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077929
application number: ANDA077929
MELOXICAMMELOXICAMNuCare Pharmaceuticals, Inc.43ca4ab6-7d52-2954-e054-00144ff88e882024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077929
application number: ANDA077929
MELOXICAMMELOXICAMBryant Ranch Prepacke5860527-f338-4073-9bb4-9f5f079469e72024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077929
application number: ANDA077929
MELOXICAMMELOXICAMProficient Rx LP3cc9741f-0574-485f-bbf5-027cb236736c2024-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077929
application number: ANDA077929
MELOXICAMMELOXICAMNCS HealthCare of KY, LLC dba Vangard Labs108397e9-672d-4061-bb74-65818c782d612023-03-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077929
application number: ANDA077929

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311486meloxicam 7.5 MG Oral TabletPSNaf9d0426-9cbb-a6a3-e053-2995a90aed2f7
311486meloxicam 7.5 MG Oral TabletSCDaf9d0426-9cbb-a6a3-e053-2995a90aed2f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0043-18042500430130 TABLET in 1 BOTTLE (80425-0043-1) 30 tablet2006-07-190000-00-00NoNoCurrent
80425-0043-28042500430260 TABLET in 1 BOTTLE (80425-0043-2) 60 tablet2006-07-190000-00-00NoNoCurrent
80425-0043-38042500430390 TABLET in 1 BOTTLE (80425-0043-3) 90 tablet2006-07-190000-00-00NoNoCurrent