Meloxicam
- Product NDC
- 71740-339
- Requested package NDC
- 71740-339-11
- 11-digit product format
- 717400339
- Labeler code
- 71740
- Product ID
- 71740-339_be6cddab-0bd4-4edf-9c3b-934744ad848c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Meloxicam
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Avondale Pharmaceuticals, LLC
- Application
- NDA021530
- Marketing category
- NDA
- 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
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| 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| N021530-001 | MELOXICAM | MELOXICAM | 7.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD, RS | 2004-06-01 |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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021530-001 | MELOXICAM | 7.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD, RS | 2004-06-01 | 84e616aacf4f… | |
| 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| 2026-07 | N021530-001 | MELOXICAM | 7.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD, RS | 2004-06-01 | caaa826d4ba7… | |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| 2026-02 | N021530-001 | MELOXICAM | 7.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD, RS | 2004-06-01 | 011fe1cb6892… | |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… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | 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… |
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
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MELOXICAM | 7.5 mg/5mL |
DailyMed Product Concepts#
| 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 | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71740-339-11 | Meloxicam | 1 in 1 CARTON | SUSPENSION | 1 | 2 | |
| 71740-339-11 | Meloxicam | 100 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 100 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71740-339-11 | ML - Milliliter | 71740-339 | 2bcebcf4-62d5-4c3d-8549-c91f37901c05 | 1 | 2022-07-06 |
DailyMed Dashboard NDC Coverage#
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.
| 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 | 021530 NDA021530 |
| Meloxicam | MELOXICAM | Avondale Pharmaceuticals, LLC | 4ddf5a4d-8e84-419d-8e3a-c91b85501885 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | 021530 NDA021530 71740-339-11 71740-339 71740033911 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 597406 | meloxicam 7.5 MG in 5 mL Oral Suspension | PSN | 4ddf5a4d-8e84-419d-8e3a-c91b85501885 | 3 |
| 597406 | meloxicam 1.5 MG/ML Oral Suspension | SCD | 4ddf5a4d-8e84-419d-8e3a-c91b85501885 | 3 |
| 597406 | meloxicam 7.5 MG per 5 ML Oral Suspension | SY | 4ddf5a4d-8e84-419d-8e3a-c91b85501885 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71740-339-11 | 71740033911 | 1 BOTTLE, PLASTIC in 1 CARTON (71740-339-11) / 100 mL in 1 BOTTLE, PLASTIC | 2022-06-21 | 0000-00-00 | No | No | Current |