Home NDC 54458-965 Meloxicam
Product NDC 54458-965
11-digit product format 544580965
Labeler code 54458
Product ID 54458-965_f4f97161-067c-4102-82a0-cd011d500583
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Meloxicam
Dosage form TABLET
Route ORAL
Labeler International Laboratories, LLC
Application ANDA077921
Marketing category ANDA
Marketing start 2008-12-01
Marketing end 0000-00-00
Substance MELOXICAM
Active strength 8 mg/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 54458-965-16 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 54458-965-10 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 54458-965-16 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 54458-965-10 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 54458-965-16 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 54458-965-10 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 54458-965-16 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 54458-965-10 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 54458-965-16 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 54458-965-10 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 54458-965-16 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 54458-965-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 54458-965-16 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 54458-965-10 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 54458-965-16 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 54458-965-10 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 54458-965-16 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 54458-965-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 54458-965-16 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 54458-965-10 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 54458-965-16 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 54458-965-10 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 54458-965-16 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 54458-965-10 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 54458-965-16 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 54458-965-16 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 54458-965-16 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54458-965-10 Meloxicam 30 in 1 BLISTER PACK TABLET 30 22 54458-965-16 Meloxicam 30 in 1 BOTTLE TABLET 30 22
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MELOXICAM ACTIVE INGREDIENT VG2QF83CGL MELOXICAM TABLET [INTERNATIONAL LABORATORIES, INC.] 15 MELOXICAM ACTIVE MOIETY VG2QF83CGL MELOXICAM TABLET [INTERNATIONAL LABORATORIES, INC.] 15 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MELOXICAM TABLET [INTERNATIONAL LABORATORIES, INC.] 15 CROSPOVIDONE (15 MPA.S AT 5%) INACTIVE INGREDIENT 68401960MK MELOXICAM TABLET [INTERNATIONAL LABORATORIES, INC.] 15 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MELOXICAM TABLET [INTERNATIONAL LABORATORIES, INC.] 15 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MELOXICAM TABLET [INTERNATIONAL LABORATORIES, INC.] 15 POVIDONES INACTIVE INGREDIENT FZ989GH94E MELOXICAM TABLET [INTERNATIONAL LABORATORIES, INC.] 15 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MELOXICAM TABLET [INTERNATIONAL LABORATORIES, INC.] 15 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K MELOXICAM TABLET [INTERNATIONAL LABORATORIES, INC.] 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54458-965 MELOXICAM TABLET [INTERNATIONAL LABORATORIES, LLC] 22 Legacy NDC, 2 package rows 20191219_06623222-188c-4ab1-976a-4cdb2037a709.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 · 23 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join meloxicam MELOXICAM A-S Medication Solutions bcfca8c6-bdba-4546-97be-1fc5601c7346 2023-09-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077921 application number: ANDA077921 meloxicam MELOXICAM Aphena Pharma Solutions - Tennessee, LLC 10c3949c-0066-4b8a-8d35-937e1ce09bf8 2021-08-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077921 application number: ANDA077921 meloxicam MELOXICAM Aphena Pharma Solutions - Tennessee, LLC 966ae650-ad7d-4de1-ab06-54992408fcfd 2021-03-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077921 application number: ANDA077921
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 54458-965-10 54458096510 30 in 1 BLISTER PACK Historical 54458-965-16 54458096516 30 TABLET in 1 BOTTLE (54458-965-16) 30 tablet 2017-05-22 0000-00-00 No No Current