Meloxicam

Product NDC
80425-0045
Requested package NDC
80425-0045-2
11-digit product format
804250045
Labeler code
80425
Product ID
80425-0045_2a989dd1-65cb-966d-e063-6294a90ae8ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA077921
Marketing category
ANDA
Marketing start
2006-07-19
Substance
MELOXICAM
Active strength
15 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

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 · 1 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
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage80425-004580425-0045-2EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…

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
A077921-001MELOXICAMMELOXICAM7.5MGTABLET / ORALAB2006-07-19
A077921-002MELOXICAMMELOXICAM15MGTABLET / ORALABRS2006-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077921-001AB
A077921-002AB

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 UTC2026-02A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077921-002MELOXICAM15MGTABLET / ORALAB2006-07-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077921-002MELOXICAM15MGTABLET / ORALAB2006-07-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077921-002MELOXICAM15MGTABLET / ORALAB2006-07-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077921-002MELOXICAM15MGTABLET / ORALAB2006-07-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077921-002MELOXICAM15MGTABLET / ORALAB2006-07-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19782e0a99824c…
2021-12-28 21:50 UTC2021-12A077921-002MELOXICAM15MGTABLET / 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 UTC2026-02A077921-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077921-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077921-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077921-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077921-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077921-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077921-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077921-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077921-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077921-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077921-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077921-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077921-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077921-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077921-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077921-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077921-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077921-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077921-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077921-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077921-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077921-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077921-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077921-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077921-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077921-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077921-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077921-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077921-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077921-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077921-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077921-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077921-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077921-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077921-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077921-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077921-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077921-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077921-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077921-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MELOXICAM15 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
152695Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
af9cde70-6c74-f6a8-e053-2995a90addafAvailable 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
80425-0045-1Meloxicam30 in 1 BOTTLETABLET307
80425-0045-2Meloxicam60 in 1 BOTTLETABLET607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0045-1EA - Each80425-0045637128ad-e331-49d4-bac9-e81e6cbc381512023-06-06
80425-0045-2EA - Each80425-00451a865591-e11c-465e-8c85-bbab2256dab012023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0045MELOXICAM TABLET [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 2 package rows20250101_af9cde70-6c74-f6a8-e053-2995a90addaf.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
meloxicamMELOXICAMREMEDYREPACK INC.7048d6cc-88a7-4743-8481-63a2005fa27a2026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077921
application number: ANDA077921
meloxicamMELOXICAMSt. Mary's Medical Park Pharmacyb710b959-a64d-a631-e053-2995a90a21772026-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077921
application number: ANDA077921
meloxicamMELOXICAMPreferred Pharmaceuticals, Inc.66bc3f93-a73b-476c-83d4-7354d2e185752026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077921
application number: ANDA077921
meloxicamMELOXICAMPreferred Pharmaceuticals Inc.e0deb1f7-b575-463f-a3f8-304cc19360752026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077921
application number: ANDA077921
meloxicamMELOXICAMCoupler LLC52bd9bcd-4902-f9dd-e063-6294a90a604e2026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077921
application number: ANDA077921
meloxicamMELOXICAMREMEDYREPACK INC.fabd063a-d3a5-44a3-90a2-e33d721b7a952026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077921
application number: ANDA077921
meloxicamMELOXICAMCoupler LLC5071e1fd-5321-42cf-e063-6294a90a0ef62026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077921
application number: ANDA077921
meloxicamMELOXICAMNuCare Pharmaceuticals,Inc.87ef5a9b-2dd1-2ef9-e053-2995a90a51492025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077921
application number: ANDA077921
MeloxicamMELOXICAMAmerican Health Packaging937ea2ca-6b8c-4c80-9926-f4de7c8f56432025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077921
application number: ANDA077921
meloxicamMELOXICAMPHOENIX RX LLC3ede6724-d9be-5b44-e063-6294a90afbaa2025-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077921
application number: ANDA077921
meloxicamMELOXICAMA-S Medication Solutions29974b41-68b4-42cf-8835-18ae480c29522025-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077921
application number: ANDA077921
MeloxicamMELOXICAMAdvanced Rx of Tennessee, LLCaf9cf496-d505-f2ba-e053-2995a90a76cf2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077921
application number: ANDA077921
MeloxicamMELOXICAMAdvanced Rx of Tennessee, LLCaf9cde70-6c74-f6a8-e053-2995a90addaf2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077921
application number: ANDA077921
ndc (package): 80425-0045-2
ndc (product): 80425-0045
ndc11 (package): 80425004502
meloxicamMELOXICAMA-S Medication Solutions7df126c1-a729-4bfe-9d08-ad359c9ee3bc2024-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077921
application number: ANDA077921
meloxicamMELOXICAMZydus Lifesciences Limited5eb2e439-2ef2-496c-9aec-042029ae13052024-11-30Exact identifier
application applno (ANDA): 077921
application number: ANDA077921
meloxicamMELOXICAMBryant Ranch Prepack37c030e7-f4f0-4923-847e-85325265960a2024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077921
application number: ANDA077921
meloxicamMELOXICAMBryant Ranch Prepackc51a641b-5715-4be9-baac-7fd4ec7295702024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077921
application number: ANDA077921
meloxicamMELOXICAMQuallent Pharmaceuticals Health LLC2875c30d-508a-46e1-ae5a-bc7057e7cbee2024-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077921
application number: ANDA077921
meloxicamMELOXICAMZydus Pharmaceuticals USA Inc.6c015f72-5ce3-4f56-8237-776fc2165b0c2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077921
application number: ANDA077921
meloxicamMELOXICAMA-S Medication Solutionsbcfca8c6-bdba-4546-97be-1fc5601c73462023-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077921
application number: ANDA077921

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSNaf9cde70-6c74-f6a8-e053-2995a90addaf7
152695meloxicam 15 MG Oral TabletSCDaf9cde70-6c74-f6a8-e053-2995a90addaf7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0045-28042500450260 TABLET in 1 BOTTLE (80425-0045-2) 60 tablet2006-07-190000-00-00NoNoCurrent