Meloxicam

Product NDC: 72919-124
11-digit product format: 729190124
Labeler code: 72919
Product ID: 72919-124_dbf69168-7068-4db3-834e-c33980303fd9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MELOXICAM
Dosage form: SUSPENSION
Route: ORAL
Labeler: Emerald Therapeutics, LLC
Application: NDA021530
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2005-11-01
Substance: MELOXICAM
Active strength: 7.5 mg/5mL
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 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021530-001	MELOXICAM	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD, RS	2004-06-01

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021530-001	MOBIC	7.5MG/5ML	SUSPENSION / ORAL	RLD	2004-06-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021530-001	MOBIC	7.5MG/5ML	SUSPENSION / ORAL	RLD	2004-06-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021530-001	MOBIC	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	2004-06-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021530-001	MOBIC	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	2004-06-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021530-001	MOBIC	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	2004-06-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021530-001	MOBIC	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	2004-06-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021530-001	MOBIC	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	2004-06-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021530-001	MOBIC	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	2004-06-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021530-001	MOBIC	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	2004-06-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021530-001	MOBIC	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	2004-06-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021530-001	MOBIC	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	2004-06-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021530-001	MOBIC	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	2004-06-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021530-001	MELOXICAM	7.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD, RS	2004-06-01	`e64feba35796…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021530-001	6184220	2019-03-25	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021530-001	6184220*PED	2019-09-25	Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021530-001	6184220	2019-03-25	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021530-001	6184220*PED	2019-09-25	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021530-001	6184220	2019-03-25	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021530-001	6184220*PED	2019-09-25	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021530-001	6184220	2019-03-25	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021530-001	6184220*PED	2019-09-25	Pediatric extension	`ea99ee380514…`

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/5mL

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
597406	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
55af77dd-2abc-49a6-990c-399d5a5e7a91	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
72919-124-10	Meloxicam	100 mL in 1 BOTTLE, PLASTIC	SUSPENSION	100		2
72919-124-10	Meloxicam	1 in 1 CARTON	SUSPENSION	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72919-124-10	ML - Milliliter	72919-124	14d3a336-7a6d-4e33-a8d9-ab6e16d51a2b	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72919-124	MELOXICAM SUSPENSION [EMERALD THERAPEUTICS, LLC]	2	Current NDC, Legacy NDC, 2 package rows	20240126_55af77dd-2abc-49a6-990c-399d5a5e7a91.zip

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meloxicam	MELOXICAM	Emerald Therapeutics, LLC	55af77dd-2abc-49a6-990c-399d5a5e7a91	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021530 application number: NDA021530 ndc (product): 72919-124
Meloxicam	MELOXICAM	Avondale Pharmaceuticals, LLC	4ddf5a4d-8e84-419d-8e3a-c91b85501885	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021530 application number: NDA021530
Zybic	MELOXICAM	Redmont Pharmaceuticals, LLC	a1c2d65f-ebb1-48bf-8fa1-c216f7d570ec	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021530 application number: NDA021530

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
597406	meloxicam 7.5 MG in 5 mL Oral Suspension	PSN	55af77dd-2abc-49a6-990c-399d5a5e7a91	3
597406	meloxicam 1.5 MG/ML Oral Suspension	SCD	55af77dd-2abc-49a6-990c-399d5a5e7a91	3
597406	meloxicam 7.5 MG per 5 ML Oral Suspension	SY	55af77dd-2abc-49a6-990c-399d5a5e7a91	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72919-124-10	72919012410	1 BOTTLE, PLASTIC in 1 CARTON (72919-124-10) / 100 mL in 1 BOTTLE, PLASTIC	2022-06-29	0000-00-00	No	No	Current