Meloxicam

Product NDC: 72189-683
Requested package NDC: 72189-683-90
11-digit product format: 721890683
Labeler code: 72189
Product ID: 72189-683_58dd9154-eca7-6e49-e063-6294a90aaf03
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Meloxicam
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA077882
Marketing category: ANDA
Marketing start: 2026-08-12
Substance: MELOXICAM
Active strength: 7.5 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 42.

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077882-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077882-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077882-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077882-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077882-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077882-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077882-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077882-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077882-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077882-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077882-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077882-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077882-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077882-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077882-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077882-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077882-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077882-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077882-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077882-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077882-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077882-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077882-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077882-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077882-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077882-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077882-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077882-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077882-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077882-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077882-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077882-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077882-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077882-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077882-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077882-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077882-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077882-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077882-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077882-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-20	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077882-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077882-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077882-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077882-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077882-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077882-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077882-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077882-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077882-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077882-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077882-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077882-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077882-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077882-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077882-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077882-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077882-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077882-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077882-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077882-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077882-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077882-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077882-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077882-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077882-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077882-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077882-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077882-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077882-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077882-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077882-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077882-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077882-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077882-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077882-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077882-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077882-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077882-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077882-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077882-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Meloxicam
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MELOXICAM	7.5 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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
58dcbc65-d126-7b48-e063-6294a90a52e9	Available on FDA.report

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meloxicam	MELOXICAM	Direct_Rx	58dbce26-b2ac-2ce4-e063-6294a90a5727	2026-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077882 application number: ANDA077882
Meloxicam	MELOXICAM	Direct_Rx	58dcbc65-d126-7b48-e063-6294a90a52e9	2026-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077882 application number: ANDA077882 ndc (package): 72189-683-90 ndc (product): 72189-683 ndc11 (package): 72189068390
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
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

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
72189-683-90	72189068390	90 TABLET in 1 BOTTLE (72189-683-90)	90 tablet	2026-08-12	0	Current