Home NDC 80425-0045 Meloxicam
Product NDC 80425-0045
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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 80425-0045 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 80425-0045 80425-0045-1 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 80425-0045 80425-0045-2 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 8dfbde2a14a4…c9ff85d89658…
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 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 80425-0045-1 Meloxicam 30 in 1 BOTTLE TABLET 30 7 80425-0045-2 Meloxicam 60 in 1 BOTTLE TABLET 60 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0045 MELOXICAM TABLET [ADVANCED RX OF TENNESSEE, LLC] 7 Current NDC, Legacy NDC, 2 package rows 20250101_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 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 80425-0045-1 80425004501 30 TABLET in 1 BOTTLE (80425-0045-1) 30 tablet 2006-07-19 0000-00-00 No No Current 80425-0045-2 80425004502 60 TABLET in 1 BOTTLE (80425-0045-2) 60 tablet 2006-07-19 0000-00-00 No No Current