Home NDC 65862-097-61 Meloxicam
Product NDC 65862-097
Requested package NDC 65862-097-61
11-digit product format 658620097
Labeler code 65862
Product ID 65862-097_40bb5ee2-b823-4a41-8f03-1d03539f74be
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Meloxicam
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA078008
Marketing category ANDA
Marketing start 2006-10-02
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 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 · 21 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 5b2001dcd8f5…54b53d4dc9e4…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078008-001 MELOXICAM MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 A078008-002 MELOXICAM MELOXICAM 15MG TABLET / ORAL AB 2006-10-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078008-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-10-02 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078008-002 MELOXICAM 15MG TABLET / ORAL AB 2006-10-02 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Meloxicam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MELOXICAM 7.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VG2QF83CGL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 152695 Internal RxNorm lookup 311486 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65862-097-01 Meloxicam 100 in 1 BOTTLE TABLET 100 21 65862-097-05 Meloxicam 500 in 1 BOTTLE TABLET 500 21 65862-097-99 Meloxicam 1000 in 1 BOTTLE TABLET 1000 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MELOXICAM ACTIVE INGREDIENT VG2QF83CGL MELOXICAM TABLET [AUROBINDO PHARMA LIMITED] 12 MELOXICAM ACTIVE MOIETY VG2QF83CGL MELOXICAM TABLET [AUROBINDO PHARMA LIMITED] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MELOXICAM TABLET [AUROBINDO PHARMA LIMITED] 12 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK MELOXICAM TABLET [AUROBINDO PHARMA LIMITED] 12 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MELOXICAM TABLET [AUROBINDO PHARMA LIMITED] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MELOXICAM TABLET [AUROBINDO PHARMA LIMITED] 12 POVIDONE K25 INACTIVE INGREDIENT K0KQV10C35 MELOXICAM TABLET [AUROBINDO PHARMA LIMITED] 12 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MELOXICAM TABLET [AUROBINDO PHARMA LIMITED] 12 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K MELOXICAM TABLET [AUROBINDO PHARMA LIMITED] 12 MELOXICAM ACTIVE INGREDIENT VG2QF83CGL MELOXICAM TABLET [MEDVANTX, INC.] 1 MELOXICAM ACTIVE MOIETY VG2QF83CGL MELOXICAM TABLET [MEDVANTX, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MELOXICAM TABLET [MEDVANTX, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK MELOXICAM TABLET [MEDVANTX, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MELOXICAM TABLET [MEDVANTX, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MELOXICAM TABLET [MEDVANTX, INC.] 1 POVIDONE K25 INACTIVE INGREDIENT K0KQV10C35 MELOXICAM TABLET [MEDVANTX, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MELOXICAM TABLET [MEDVANTX, INC.] 1 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K MELOXICAM TABLET [MEDVANTX, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-097 MELOXICAM TABLET [AUROBINDO PHARMA LIMITED] 21 Current NDC, Legacy NDC, 3 package rows 20250317_d5e12448-1ca1-46a4-8de4-e8b94567e5a8.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Status 65862-097-61 65862009761 6000 TABLET in 1 BAG (65862-097-61) 6000 tablet 02-OCT-06 Current