Meloxicam

Product NDC: 80425-0585
Requested package NDC: 80425-0585-3
11-digit product format: 804250585
Labeler code: 80425
Product ID: 80425-0585_57126403-c27a-e7d2-e063-6294a90abea6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Meloxicam
Dosage form: TABLET
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA077882
Marketing category: ANDA
Marketing start: 2026-06-18
Substance: MELOXICAM
Active strength: 15 mg/1
Pharmacologic classes: Anti-Inflammatory Agents; Non-Steroidal [CS]; Cyclooxygenase Inhibitors [MoA]; Nonsteroidal Anti-inflammatory Drug [EPC]
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A077882-001	MELOXICAM	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-20
A077882-002	MELOXICAM	MELOXICAM	15MG	TABLET / ORAL	AB		2006-07-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A077882-001	AB
A077882-002	AB

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.

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
2026-08-01 22:54:32	2026-06	A077882-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077882-002	MELOXICAM	15MG	TABLET / ORAL	AB		2006-07-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A077882-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077882-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	5488ccc1-e416-e5d7-e063-6294a90a6cb8	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077882 application number: ANDA077882
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	548ec3b7-2b6d-cd9e-e063-6394a90a78ff	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077882 application number: ANDA077882 ndc (package): 80425-0585-3 ndc (product): 80425-0585 ndc11 (package): 80425058503
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	548ef3ed-ab67-ec85-e063-6294a90ab1da	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077882 application number: ANDA077882
Meloxicam	MELOXICAM	Terrain Pharmaceuticals, Inc.	b603255e-1fcf-42ec-ab62-9aa321cb7ac6	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077882 application number: ANDA077882
Meloxicam	MELOXICAM	Bryant Ranch Prepack	7895f389-1509-4e03-8668-526ab1627fc8	2026-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077882 application number: ANDA077882
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	445d7cbf-bd3e-a54f-e063-6294a90a67a5	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077882 application number: ANDA077882
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	445dc4f6-daac-e2f1-e063-6394a90a0ca5	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077882 application number: ANDA077882
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	453c5328-090e-0159-e063-6394a90a06b7	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077882 application number: ANDA077882

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
548ec3b7-2b6d-cd9e-e063-6394a90a78ff	Available on FDA.report

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VG2QF83CGL	MELOXICAM	71125-38-7	MELOXICAM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Status
80425-0585-3	80425058503	90 TABLET in 1 BOTTLE (80425-0585-3)	90 tablet	2026-06-18	0	Current