Home NDC 16571-776 Meloxicam
Product NDC 16571-776
11-digit product format 165710776
Labeler code 16571
Product ID 16571-776_addfc853-b1a7-43dd-b75e-3fc83811509c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Meloxicam
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA078008
Marketing category ANDA
Marketing start 2006-10-02
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 2022-12-31
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 16571-776-50 excluded package package 16571-776-01 excluded package package 16571-776-10
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.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16571-776 MELOXICAM TABLET [RISING PHARMA HOLDINGS, INC.] 6 Legacy NDC 20250321_b4bcb395-0164-4720-9823-967769b4ce67.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Meloxicam MELOXICAM Aurobindo Pharma Limited d5e12448-1ca1-46a4-8de4-e8b94567e5a8 2025-03-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078008 application number: ANDA078008
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16571-776-01 16571077601 100 TABLET in 1 BOTTLE (16571-776-01) 100 tablet 2006-10-02 0000-00-00 No No Current 16571-776-10 16571077610 1000 TABLET in 1 BOTTLE (16571-776-10) 1000 tablet 2006-10-02 0000-00-00 No No Current 16571-776-50 16571077650 500 TABLET in 1 BOTTLE (16571-776-50) 500 tablet 2006-10-02 0000-00-00 No No Current