Meloxicam

Product NDC: 80425-0558
11-digit product format: 804250558
Labeler code: 80425
Product ID: 80425-0558_4538a916-9d71-be91-e063-6294a90a54e1
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: 2025-11-24
Substance: MELOXICAM
Active strength: 7.5 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

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
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 · 86 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
2026-09-14 22:38:34	2026-08	A077882-001	MELOXICAM	7.5MG	TABLET / ORAL	AB	2006-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077882-002	MELOXICAM	15MG	TABLET / ORAL	AB	2006-07-20	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077882-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077882-002	AB	1	`84e616aacf4f…`
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…`

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	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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311486	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
445d7cbf-bd3e-a54f-e063-6294a90a67a5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bdef11ce-16e2-4690-96a3-597bcf5cc738	Product name	1	20260130
f2791553-0b76-42f4-8d49-af3eda072bfb	Product name	1	20251117
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
e3a99641-4540-4894-9108-00cab3c57b7e	Product name	1	20211207
3e9b4ed6-844c-4725-9d19-cceb5c823572	Product name	2	20210903
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
b21a682e-c765-4e26-9bb2-dbb8c7b38ef7	Product name	1	20200623
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
a428d1db-64d7-4fc3-8d13-832b1e84b683	Product name	1	20190201
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
96649a58-aac8-401c-be00-450b4335f7e7	Product name	1	20161116
f0761cb7-8207-3a19-2ca3-ecbb559b04e1	Product name	2	20161116
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80425-0558-1	Meloxicam	30 in 1 BOTTLE	TABLET	30	2
80425-0558-2	Meloxicam	60 in 1 BOTTLE	TABLET	60	2
80425-0558-3	Meloxicam	90 in 1 BOTTLE	TABLET	90	2
80425-0558-4	Meloxicam	120 in 1 BOTTLE	TABLET	120	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0558-1	EA - Each	80425-0558	af61d76d-4823-4a01-907a-b0fb37a1f69c	1	2026-01-08
80425-0558-2	EA - Each	80425-0558	95cb0eb7-fe6e-4b59-a90f-ac6c286ea169	1	2026-01-08
80425-0558-3	EA - Each	80425-0558	1af76c50-d821-4ebf-9d6b-2bdafc3a980a	1	2026-01-08
80425-0558-4	EA - Each	80425-0558	e028eb31-232c-48c9-ad4f-c13a8eec79ec	1	2026-01-08

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 · 9 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	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 ndc (product): 80425-0558
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311486	meloxicam 7.5 MG Oral Tablet	PSN	445d7cbf-bd3e-a54f-e063-6294a90a67a5	2
311486	meloxicam 7.5 MG Oral Tablet	SCD	445d7cbf-bd3e-a54f-e063-6294a90a67a5	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0558-1	80425055801	30 TABLET in 1 BOTTLE (80425-0558-1)	30 tablet	2025-11-24	No	No	Current
80425-0558-2	80425055802	60 TABLET in 1 BOTTLE (80425-0558-2)	60 tablet	2025-11-24	No	No	Current
80425-0558-3	80425055803	90 TABLET in 1 BOTTLE (80425-0558-3)	90 tablet	2025-11-24	No	No	Current
80425-0558-4	80425055804	120 TABLET in 1 BOTTLE (80425-0558-4)	120 tablet	2025-11-24	No	No	Current