meloxicam

Product NDC: 70518-0039
Requested package NDC: 70518-0039-5
11-digit product format: 705180039
Labeler code: 70518
Product ID: 70518-0039_4cd5555e-a5fe-eef2-e063-6294a90a7feb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: meloxicam
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA077927
Marketing category: ANDA
Marketing start: 2016-12-06
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: 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
A077927-001	MELOXICAM	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-12-20
A077927-002	MELOXICAM	MELOXICAM	15MG	TABLET / ORAL	AB		2006-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077927-001	AB
A077927-002	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	A077927-001	MELOXICAM	7.5MG	TABLET / ORAL	AB		2006-12-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077927-002	MELOXICAM	15MG	TABLET / ORAL	AB		2006-12-20	`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	A077927-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077927-002	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 2 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
meloxicam	MELOXICAM	Coupler LLC	56440abd-80f4-7b8d-e063-6394a90a2a91	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	HAWAII REPACK, INC.	68b50c82-7130-428a-884c-98576887e99a	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	REMEDYREPACK INC.	5d153147-f1c8-4624-8028-fe84680d7143	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	REMEDYREPACK INC.	3e8a6283-1e1b-4199-ac73-f42255c7e907	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	REMEDYREPACK INC.	ffaf1db4-25a9-48d1-a624-242f9d8e14c7	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927 ndc (package): 70518-0039-5 ndc (product): 70518-0039 ndc11 (package): 70518003905
meloxicam	MELOXICAM	St. Mary's Medical Park Pharmacy	60c954d5-bd5a-33f9-e053-2a91aa0ab597	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	St. Mary's Medical Park Pharmacy	60c9ab35-4b6e-383d-e053-2a91aa0a26ad	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	Proficient Rx LP	459bd9c0-1102-46d3-8020-5fec80d1ec36	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	Sportpharm LLC	f210e6b4-43b3-4d33-bc0b-013a0f907d3e	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	PD-Rx Pharmaceuticals, Inc.	1d8b617a-b9b3-473c-be9b-f34a585a1b3b	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
MELOXICAM	MELOXICAM	Direct Rx	c172a767-eb26-4995-b2a2-f3c5e87b4943	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
Meloxicam	MELOXICAM	Advanced Rx of Tennessee, LLC	af9ce58c-3cd7-769f-e053-2a95a90a5385	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	Preferred Pharmaceuticals Inc.	c6f37980-8e09-4f2e-a768-b3d22cbe3d49	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	Northwind Health Company, LLC	3ce43f4a-c525-4ce1-b328-514b3912e305	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	Northwind Health Company, LLC	820f143f-4b0c-4466-be9a-212dab9d984b	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	PHOENIX RX LLC	438311de-78e7-8bd9-e063-6394a90a7932	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	QPharma, Inc.	20ec4646-9d1c-41c9-93f6-754b3a4f234f	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	A-S Medication Solutions	67974608-326e-4e62-8430-6fbc14d1d69b	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	QPharma, Inc.	14e7472a-24fe-4ae1-abc7-c2972ce8cd74	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927
meloxicam	MELOXICAM	A-S Medication Solutions	11984306-9b71-4c2a-81bc-8942966810be	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077927 application number: ANDA077927

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 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
ffaf1db4-25a9-48d1-a624-242f9d8e14c7	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	SPL version
70518-0039-0	meloxicam	40 in 1 BOTTLE	TABLET	40	24
70518-0039-1	meloxicam	30 in 1 BOTTLE, PLASTIC	TABLET	30	24
70518-0039-2	meloxicam	90 in 1 BOTTLE, PLASTIC	TABLET	90	24
70518-0039-3	meloxicam	20 in 1 BOTTLE, PLASTIC	TABLET	20	24
70518-0039-4	meloxicam	50 in 1 BOTTLE, PLASTIC	TABLET	50	24
70518-0039-5	meloxicam	15 in 1 BOTTLE, PLASTIC	TABLET	15	24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-0039	MELOXICAM TABLET [REMEDYREPACK INC.]	19	Current NDC, Legacy NDC, 6 package rows	20250524_ffaf1db4-25a9-48d1-a624-242f9d8e14c7.zip

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	ffaf1db4-25a9-48d1-a624-242f9d8e14c7	24
311486	meloxicam 7.5 MG Oral Tablet	SCD	ffaf1db4-25a9-48d1-a624-242f9d8e14c7	24

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-0039-5	70518003905	15 TABLET in 1 BOTTLE, PLASTIC (70518-0039-5)	15 tablet	2025-10-09	No	No	Current