Home NDC 68382-050 meloxicam
Product NDC 68382-050
11-digit product format 683820050
Labeler code 68382
Product ID 68382-050_87e6ffb9-5a3c-4579-bf50-db901cbdeca9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name meloxicam
Dosage form TABLET
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA077921
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A077921-001 MELOXICAM MELOXICAM 7.5MG TABLET / ORAL AB 2006-07-19 A077921-002 MELOXICAM MELOXICAM 15MG TABLET / ORAL AB RS 2006-07-19
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 · 86 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 2026-09-14 22:38:34 2026-08 A077921-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077921-002 MELOXICAM 15MG TABLET / ORAL AB RS 2006-07-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077921-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077921-002 MELOXICAM 15MG TABLET / ORAL AB RS 2006-07-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077921-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077921-002 MELOXICAM 15MG TABLET / ORAL AB RS 2006-07-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077921-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077921-002 MELOXICAM 15MG TABLET / ORAL AB RS 2006-07-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077921-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077921-002 MELOXICAM 15MG TABLET / ORAL AB RS 2006-07-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077921-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077921-002 MELOXICAM 15MG TABLET / ORAL AB RS 2006-07-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077921-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077921-002 MELOXICAM 15MG TABLET / ORAL AB RS 2006-07-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077921-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077921-002 MELOXICAM 15MG TABLET / ORAL AB RS 2006-07-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077921-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077921-002 MELOXICAM 15MG TABLET / ORAL AB RS 2006-07-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077921-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077921-002 MELOXICAM 15MG TABLET / ORAL AB RS 2006-07-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077921-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-07-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077921-002 MELOXICAM 15MG TABLET / ORAL AB RS 2006-07-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077921-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-07-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077921-002 MELOXICAM 15MG TABLET / ORAL AB RS 2006-07-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077921-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-07-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077921-002 MELOXICAM 15MG TABLET / ORAL AB RS 2006-07-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077921-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-07-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077921-002 MELOXICAM 15MG TABLET / ORAL AB RS 2006-07-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077921-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-07-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077921-002 MELOXICAM 15MG TABLET / ORAL AB RS 2006-07-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077921-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-07-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077921-002 MELOXICAM 15MG TABLET / ORAL AB RS 2006-07-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077921-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-07-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077921-002 MELOXICAM 15MG TABLET / ORAL AB 2006-07-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077921-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-07-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077921-002 MELOXICAM 15MG TABLET / ORAL AB 2006-07-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077921-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-07-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077921-002 MELOXICAM 15MG TABLET / ORAL AB 2006-07-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077921-001 MELOXICAM 7.5MG TABLET / ORAL AB 2006-07-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077921-002 MELOXICAM 15MG TABLET / ORAL AB 2006-07-19 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MELOXICAM ACTIVE INGREDIENT VG2QF83CGL MELOXICAM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 11 MELOXICAM ACTIVE MOIETY VG2QF83CGL MELOXICAM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 11 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MELOXICAM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 11 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK MELOXICAM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 11 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MELOXICAM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MELOXICAM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 11 POVIDONE INACTIVE INGREDIENT FZ989GH94E MELOXICAM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 11 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MELOXICAM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 11 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K MELOXICAM TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 11 MELOXICAM ACTIVE INGREDIENT VG2QF83CGL MELOXICAM TABLET MELOXICAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 MELOXICAM ACTIVE MOIETY VG2QF83CGL MELOXICAM TABLET MELOXICAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MELOXICAM TABLET MELOXICAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 CROSPOVIDONE (15 MPA.S AT 5%) INACTIVE INGREDIENT 68401960MK MELOXICAM TABLET MELOXICAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MELOXICAM TABLET MELOXICAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MELOXICAM TABLET MELOXICAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 POVIDONES INACTIVE INGREDIENT FZ989GH94E MELOXICAM TABLET MELOXICAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MELOXICAM TABLET MELOXICAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K MELOXICAM TABLET MELOXICAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 MELOXICAM ACTIVE INGREDIENT VG2QF83CGL MELOXICAM TABLET [CARILION MATERIALS MANAGEMENT] 2 MELOXICAM ACTIVE MOIETY VG2QF83CGL MELOXICAM TABLET [CARILION MATERIALS MANAGEMENT] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MELOXICAM TABLET [CARILION MATERIALS MANAGEMENT] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK MELOXICAM TABLET [CARILION MATERIALS MANAGEMENT] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MELOXICAM TABLET [CARILION MATERIALS MANAGEMENT] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MELOXICAM TABLET [CARILION MATERIALS MANAGEMENT] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E MELOXICAM TABLET [CARILION MATERIALS MANAGEMENT] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MELOXICAM TABLET [CARILION MATERIALS MANAGEMENT] 2 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K MELOXICAM TABLET [CARILION MATERIALS MANAGEMENT] 2 MELOXICAM ACTIVE INGREDIENT VG2QF83CGL MELOXICAM TABLET [MEDVANTX, INC.] 1 MELOXICAM ACTIVE INGREDIENT VG2QF83CGL MELOXICAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 MELOXICAM ACTIVE MOIETY VG2QF83CGL MELOXICAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 MELOXICAM ACTIVE MOIETY VG2QF83CGL MELOXICAM TABLET [MEDVANTX, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MELOXICAM TABLET [MEDVANTX, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MELOXICAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK MELOXICAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK MELOXICAM TABLET [MEDVANTX, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MELOXICAM TABLET [MEDVANTX, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MELOXICAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MELOXICAM TABLET [MEDVANTX, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MELOXICAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E MELOXICAM TABLET [MEDVANTX, INC.] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E MELOXICAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MELOXICAM TABLET [MEDVANTX, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MELOXICAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K MELOXICAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 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 68382-050 MELOXICAM TABLET [ZYDUS PHARMACEUTICALS USA INC.] 24 Current NDC, Legacy NDC, 6 package rows 20241003_6c015f72-5ce3-4f56-8237-776fc2165b0c.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 2 of 2 · 22 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68382-050-01 68382005001 100 TABLET in 1 BOTTLE (68382-050-01) 100 tablet 2006-07-19 0000-00-00 No No Current 68382-050-05 68382005005 500 TABLET in 1 BOTTLE (68382-050-05) 500 tablet 2006-07-19 0000-00-00 No No Current 68382-050-16 68382005016 90 TABLET in 1 BOTTLE (68382-050-16) 90 tablet 2006-07-19 0000-00-00 No No Current 68382-050-30 68382005030 10 in 1 BLISTER PACK Historical 68382-050-40 68382005040 5000 TABLET in 1 BOTTLE (68382-050-40) 5000 tablet 2006-07-19 0000-00-00 No No Current 68382-050-77 68382005077 10 BLISTER PACK in 1 CARTON (68382-050-77) / 10 TABLET in 1 BLISTER PACK (68382-050-30) 10 blister pack 2006-07-19 0000-00-00 No No Current