Home NDC 67046-0891 meloxicam
Product NDC 67046-0891
11-digit product format 670460891
Labeler code 67046
Product ID 67046-0891_52bd961a-49ef-f483-e063-6294a90a067e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name meloxicam
Dosage form TABLET
Route ORAL
Labeler Coupler LLC
Application ANDA077921
Marketing category ANDA
Marketing start 2026-05-26
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 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MELOXICAM 15 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 152695 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 67046-0891-3 meloxicam 30 in 1 BLISTER PACK TABLET 30 1
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 Sample Exclude flag Status 67046-0891-3 67046089103 30 TABLET in 1 BLISTER PACK (67046-0891-3) 30 tablet 2026-05-26 No No Current