meloxicam

Product NDC
68788-8801
11-digit product format
687888801
Labeler code
68788
Product ID
68788-8801_ef3447a9-ed6a-4cba-9681-09ae9dc8b630
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077927
Marketing category
ANDA
Marketing start
2025-01-02
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

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
A077927-001MELOXICAMMELOXICAM7.5MGTABLET / ORALAB2006-12-20
A077927-002MELOXICAMMELOXICAM15MGTABLET / ORALAB2006-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077927-001AB
A077927-002AB

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 UTC2026-02A077927-001MELOXICAM7.5MGTABLET / ORALAB2006-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077927-002MELOXICAM15MGTABLET / ORALAB2006-12-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077927-001MELOXICAM7.5MGTABLET / ORALAB2006-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077927-002MELOXICAM15MGTABLET / ORALAB2006-12-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077927-001MELOXICAM7.5MGTABLET / ORALAB2006-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077927-002MELOXICAM15MGTABLET / ORALAB2006-12-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077927-001MELOXICAM7.5MGTABLET / ORALAB2006-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077927-002MELOXICAM15MGTABLET / ORALAB2006-12-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077927-001MELOXICAM7.5MGTABLET / ORALAB2006-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077927-002MELOXICAM15MGTABLET / ORALAB2006-12-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077927-001MELOXICAM7.5MGTABLET / ORALAB2006-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077927-002MELOXICAM15MGTABLET / ORALAB2006-12-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077927-001MELOXICAM7.5MGTABLET / ORALAB2006-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077927-002MELOXICAM15MGTABLET / ORALAB2006-12-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077927-001MELOXICAM7.5MGTABLET / ORALAB2006-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077927-002MELOXICAM15MGTABLET / ORALAB2006-12-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077927-001MELOXICAM7.5MGTABLET / ORALAB2006-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077927-002MELOXICAM15MGTABLET / ORALAB2006-12-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077927-001MELOXICAM7.5MGTABLET / ORALAB2006-12-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A077927-002MELOXICAM15MGTABLET / ORALAB2006-12-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077927-001MELOXICAM7.5MGTABLET / ORALAB2006-12-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077927-002MELOXICAM15MGTABLET / ORALAB2006-12-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077927-001MELOXICAM7.5MGTABLET / ORALAB2006-12-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077927-002MELOXICAM15MGTABLET / ORALAB2006-12-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077927-001MELOXICAM7.5MGTABLET / ORALAB2006-12-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077927-002MELOXICAM15MGTABLET / ORALAB2006-12-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077927-001MELOXICAM7.5MGTABLET / ORALAB2006-12-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077927-002MELOXICAM15MGTABLET / ORALAB2006-12-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077927-001MELOXICAM7.5MGTABLET / ORALAB2006-12-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077927-002MELOXICAM15MGTABLET / ORALAB2006-12-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077927-001MELOXICAM7.5MGTABLET / ORALAB2006-12-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077927-002MELOXICAM15MGTABLET / ORALAB2006-12-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077927-001MELOXICAM7.5MGTABLET / ORALAB2006-12-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077927-002MELOXICAM15MGTABLET / ORALAB2006-12-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077927-001MELOXICAM7.5MGTABLET / ORALAB2006-12-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077927-002MELOXICAM15MGTABLET / ORALAB2006-12-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077927-001MELOXICAM7.5MGTABLET / ORALAB2006-12-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077927-002MELOXICAM15MGTABLET / ORALAB2006-12-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077927-001MELOXICAM7.5MGTABLET / ORALAB2006-12-20782e0a99824c…
2021-12-28 21:50 UTC2021-12A077927-002MELOXICAM15MGTABLET / ORALAB2006-12-20782e0a99824c…

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 UTC2026-02A077927-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077927-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077927-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077927-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077927-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077927-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077927-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077927-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077927-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077927-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077927-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077927-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077927-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077927-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077927-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077927-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077927-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077927-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077927-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077927-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077927-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077927-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077927-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077927-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077927-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077927-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077927-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077927-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077927-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077927-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077927-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077927-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077927-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077927-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077927-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077927-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077927-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077927-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077927-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077927-002AB1782e0a99824c…

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
ef3447a9-ed6a-4cba-9681-09ae9dc8b630Available 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
68788-8801-0meloxicam100 in 1 BOTTLETABLET1001
68788-8801-1meloxicam15 in 1 BOTTLETABLET151
68788-8801-2meloxicam20 in 1 BOTTLETABLET201
68788-8801-3meloxicam30 in 1 BOTTLETABLET301
68788-8801-4meloxicam14 in 1 BOTTLETABLET141
68788-8801-6meloxicam60 in 1 BOTTLETABLET601
68788-8801-7meloxicam7 in 1 BOTTLETABLET71
68788-8801-8meloxicam28 in 1 BOTTLETABLET281
68788-8801-9meloxicam90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8801-0EA - Each68788-8801c8179eae-39dc-44c0-aec8-cb91e8067d4a12025-02-10
68788-8801-1EA - Each68788-8801f02932fb-89ae-4488-bf10-cdda5757f16312025-02-10
68788-8801-2EA - Each68788-88013aa64a73-01f2-4fdc-9567-81e8089a142f12025-02-10
68788-8801-3EA - Each68788-8801d06be73d-9fd7-4e69-a659-650618181e1c12025-02-10
68788-8801-4EA - Each68788-8801f6df5526-1fc1-4f49-b2a0-519cd40f2e5e12025-02-10
68788-8801-6EA - Each68788-8801d9c779d1-574c-479a-a6b8-9bf793e5031212025-02-10
68788-8801-7EA - Each68788-8801eb2359bd-6afd-4b6e-8dbd-c3eebc0918ae12025-02-10
68788-8801-8EA - Each68788-8801e744741a-9a81-4f2e-9a0b-bb19a8548afd12025-02-10
68788-8801-9EA - Each68788-88015cf4237b-2d68-4464-87e5-47a3c78489ae12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8801MELOXICAM TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 9 package rows20250104_ef3447a9-ed6a-4cba-9681-09ae9dc8b630.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 · 38 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
meloxicamMELOXICAMCoupler LLC56440abd-80f4-7b8d-e063-6394a90a2a912026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077927
application number: ANDA077927
meloxicamMELOXICAMHAWAII REPACK, INC.68b50c82-7130-428a-884c-98576887e99a2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077927
application number: ANDA077927
meloxicamMELOXICAMREMEDYREPACK INC.5d153147-f1c8-4624-8028-fe84680d71432026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077927
application number: ANDA077927
meloxicamMELOXICAMREMEDYREPACK INC.3e8a6283-1e1b-4199-ac73-f42255c7e9072026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077927
application number: ANDA077927
meloxicamMELOXICAMREMEDYREPACK INC.ffaf1db4-25a9-48d1-a624-242f9d8e14c72026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077927
application number: ANDA077927
meloxicamMELOXICAMSt. Mary's Medical Park Pharmacy60c954d5-bd5a-33f9-e053-2a91aa0ab5972026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077927
application number: ANDA077927
meloxicamMELOXICAMSt. Mary's Medical Park Pharmacy60c9ab35-4b6e-383d-e053-2a91aa0a26ad2026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077927
application number: ANDA077927
meloxicamMELOXICAMProficient Rx LP459bd9c0-1102-46d3-8020-5fec80d1ec362026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077927
application number: ANDA077927
meloxicamMELOXICAMSportpharm LLCf210e6b4-43b3-4d33-bc0b-013a0f907d3e2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077927
application number: ANDA077927
meloxicamMELOXICAMPD-Rx Pharmaceuticals, Inc.1d8b617a-b9b3-473c-be9b-f34a585a1b3b2026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077927
application number: ANDA077927
MELOXICAMMELOXICAMDirect Rxc172a767-eb26-4995-b2a2-f3c5e87b49432026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077927
application number: ANDA077927
MeloxicamMELOXICAMAdvanced Rx of Tennessee, LLCaf9ce58c-3cd7-769f-e053-2a95a90a53852026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077927
application number: ANDA077927
meloxicamMELOXICAMPreferred Pharmaceuticals Inc.c6f37980-8e09-4f2e-a768-b3d22cbe3d492026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077927
application number: ANDA077927
meloxicamMELOXICAMNorthwind Health Company, LLC3ce43f4a-c525-4ce1-b328-514b3912e3052026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077927
application number: ANDA077927
meloxicamMELOXICAMNorthwind Health Company, LLC820f143f-4b0c-4466-be9a-212dab9d984b2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077927
application number: ANDA077927
meloxicamMELOXICAMPHOENIX RX LLC438311de-78e7-8bd9-e063-6394a90a79322025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077927
application number: ANDA077927
meloxicamMELOXICAMQPharma, Inc.20ec4646-9d1c-41c9-93f6-754b3a4f234f2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077927
application number: ANDA077927
meloxicamMELOXICAMA-S Medication Solutions67974608-326e-4e62-8430-6fbc14d1d69b2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077927
application number: ANDA077927
meloxicamMELOXICAMQPharma, Inc.14e7472a-24fe-4ae1-abc7-c2972ce8cd742025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077927
application number: ANDA077927
meloxicamMELOXICAMA-S Medication Solutions11984306-9b71-4c2a-81bc-8942966810be2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077927
application number: ANDA077927

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152695meloxicam 15 MG Oral TabletPSNef3447a9-ed6a-4cba-9681-09ae9dc8b6301
152695meloxicam 15 MG Oral TabletSCDef3447a9-ed6a-4cba-9681-09ae9dc8b6301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8801-068788880100100 TABLET in 1 BOTTLE (68788-8801-0) 100 tablet2025-01-02NoNoCurrent
68788-8801-16878888010115 TABLET in 1 BOTTLE (68788-8801-1) 15 tablet2025-01-02NoNoCurrent
68788-8801-26878888010220 TABLET in 1 BOTTLE (68788-8801-2) 20 tablet2025-01-02NoNoCurrent
68788-8801-36878888010330 TABLET in 1 BOTTLE (68788-8801-3) 30 tablet2025-01-02NoNoCurrent
68788-8801-46878888010414 TABLET in 1 BOTTLE (68788-8801-4) 14 tablet2025-01-02NoNoCurrent
68788-8801-66878888010660 TABLET in 1 BOTTLE (68788-8801-6) 60 tablet2025-01-02NoNoCurrent
68788-8801-7687888801077 TABLET in 1 BOTTLE (68788-8801-7) 7 tablet2025-01-02NoNoCurrent
68788-8801-86878888010828 TABLET in 1 BOTTLE (68788-8801-8) 28 tablet2025-01-02NoNoCurrent
68788-8801-96878888010990 TABLET in 1 BOTTLE (68788-8801-9) 90 tablet2025-01-02NoNoCurrent