meloxicam

Product NDC: 67046-0891
11-digit product format: 670460891
Labeler code: 67046
Product ID: 67046-0891_52bd961a-49ef-f483-e063-6294a90a067e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: meloxicam
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA077921
Marketing category: ANDA
Marketing start: 2026-05-26
Substance: MELOXICAM
Active strength: 15 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: 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
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.

Application-product, TE code table
Application-product	TE code
A077921-001	AB
A077921-002	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 · 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	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…`
2022-03-09 01:35 UTC	2022-03	A077921-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077921-002	MELOXICAM	15MG	TABLET / ORAL	AB		2006-07-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077921-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-07-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077921-002	MELOXICAM	15MG	TABLET / ORAL	AB		2006-07-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077921-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077921-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077921-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077921-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077921-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077921-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077921-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077921-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077921-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077921-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077921-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077921-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077921-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077921-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077921-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077921-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077921-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077921-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077921-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077921-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077921-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077921-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077921-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077921-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077921-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077921-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077921-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077921-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077921-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077921-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077921-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077921-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077921-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077921-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077921-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077921-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077921-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077921-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077921-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077921-002	AB	1	`782e0a99824c…`

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
52bd9bcd-4902-f9dd-e063-6294a90a604e	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
e3a99641-4540-4894-9108-00cab3c57b7e	Product name	1	20211207
3e9b4ed6-844c-4725-9d19-cceb5c823572	Product name	2	20210903
b21a682e-c765-4e26-9bb2-dbb8c7b38ef7	Product name	1	20200623
a428d1db-64d7-4fc3-8d13-832b1e84b683	Product name	1	20190201
96649a58-aac8-401c-be00-450b4335f7e7	Product name	1	20161116
f0761cb7-8207-3a19-2ca3-ecbb559b04e1	Product name	2	20161116

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67046-0891-3	meloxicam	30 in 1 BLISTER PACK	TABLET	30		1

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
meloxicam	MELOXICAM	St. Mary's Medical Park Pharmacy	b710b959-a64d-a631-e053-2995a90a2177	2026-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	Preferred Pharmaceuticals, Inc.	66bc3f93-a73b-476c-83d4-7354d2e18575	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	Preferred Pharmaceuticals Inc.	e0deb1f7-b575-463f-a3f8-304cc1936075	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	Coupler LLC	52bd9bcd-4902-f9dd-e063-6294a90a604e	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921 ndc (product): 67046-0891
meloxicam	MELOXICAM	REMEDYREPACK INC.	fabd063a-d3a5-44a3-90a2-e33d721b7a95	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	Coupler LLC	5071e1fd-5321-42cf-e063-6294a90a0ef6	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	REMEDYREPACK INC.	7048d6cc-88a7-4743-8481-63a2005fa27a	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	NuCare Pharmaceuticals,Inc.	87ef5a9b-2dd1-2ef9-e053-2995a90a5149	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
Meloxicam	MELOXICAM	American Health Packaging	937ea2ca-6b8c-4c80-9926-f4de7c8f5643	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	PHOENIX RX LLC	3ede6724-d9be-5b44-e063-6294a90afbaa	2025-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	A-S Medication Solutions	29974b41-68b4-42cf-8835-18ae480c2952	2025-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	af9cf496-d505-f2ba-e053-2995a90a76cf	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	af9cde70-6c74-f6a8-e053-2995a90addaf	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	A-S Medication Solutions	7df126c1-a729-4bfe-9d08-ad359c9ee3bc	2024-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	Zydus Lifesciences Limited	5eb2e439-2ef2-496c-9aec-042029ae1305	2024-11-30		Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	Bryant Ranch Prepack	37c030e7-f4f0-4923-847e-85325265960a	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	Bryant Ranch Prepack	c51a641b-5715-4be9-baac-7fd4ec729570	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	Quallent Pharmaceuticals Health LLC	2875c30d-508a-46e1-ae5a-bc7057e7cbee	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
meloxicam	MELOXICAM	Zydus Pharmaceuticals USA Inc.	6c015f72-5ce3-4f56-8237-776fc2165b0c	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077921 application number: ANDA077921
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

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
152695	meloxicam 15 MG Oral Tablet	PSN	52bd9bcd-4902-f9dd-e063-6294a90a604e	1
152695	meloxicam 15 MG Oral Tablet	SCD	52bd9bcd-4902-f9dd-e063-6294a90a604e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-0891-3	67046089103	30 TABLET in 1 BLISTER PACK (67046-0891-3)	30 tablet	2026-05-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
meloxicam	Coupler LLC \| Zydus Pharmaceuticals USA Inc.	2026-05-26	HUMAN PRESCRIPTION DRUG LABEL	1