Mobic

Product NDC
55289-618
Requested package NDC
55289-618-14
11-digit product format
552890618
Labeler code
55289
Product ID
55289-618_da326033-efe8-8b06-e053-2a95a90a6588
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meloxicam
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
NDA020938
Marketing category
NDA
Marketing start
2001-06-25
Marketing end
0000-00-00
Substance
MELOXICAM
Active strength
8 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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55289-61855289-618-14DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020938-001MOBICMELOXICAM7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-13
N020938-002MOBICMELOXICAM15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-08-23

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020938-001MOBIC7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020938-002MOBIC15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-08-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020938-001MOBIC7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020938-002MOBIC15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-08-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N020938-001MOBIC7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020938-002MOBIC15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-08-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020938-001MOBIC7.5MGTABLET / ORALRLD2000-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020938-002MOBIC15MGTABLET / ORALRLD2000-08-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020938-001MOBIC7.5MGTABLET / ORALRLD2000-04-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020938-002MOBIC15MGTABLET / ORALRLD2000-08-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020938-001MOBIC7.5MGTABLET / ORALRLD2000-04-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020938-002MOBIC15MGTABLET / ORALRLD2000-08-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020938-001MOBIC7.5MGTABLET / ORALRLD2000-04-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020938-002MOBIC15MGTABLET / ORALRLD2000-08-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020938-001MOBIC7.5MGTABLET / ORALRLD2000-04-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020938-002MOBIC15MGTABLET / ORALRLD2000-08-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020938-001MOBIC7.5MGTABLET / ORALRLD2000-04-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020938-002MOBIC15MGTABLET / ORALRLD2000-08-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020938-001MOBIC7.5MGTABLET / ORALRLD2000-04-13d06236e962d9…
2024-10-29 15:01 UTC2024-10N020938-002MOBIC15MGTABLET / ORALRLD2000-08-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020938-001MOBIC7.5MGTABLET / ORALRLD2000-04-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020938-002MOBIC15MGTABLET / ORALRLD2000-08-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020938-001MOBIC7.5MGTABLET / ORALRLD2000-04-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020938-002MOBIC15MGTABLET / ORALRLD2000-08-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020938-001MOBIC7.5MGTABLET / ORALRLD2000-04-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020938-002MOBIC15MGTABLET / ORALRLD2000-08-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020938-001MOBIC7.5MGTABLET / ORALRLD2000-04-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020938-002MOBIC15MGTABLET / ORALRLD2000-08-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020938-001MOBIC7.5MGTABLET / ORALABRLD2000-04-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020938-002MOBIC15MGTABLET / ORALABRLD, RS2000-08-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020938-001MOBIC7.5MGTABLET / ORALABRLD2000-04-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020938-002MOBIC15MGTABLET / ORALABRLD, RS2000-08-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020938-001MOBIC7.5MGTABLET / ORALABRLD2000-04-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020938-002MOBIC15MGTABLET / ORALABRLD, RS2000-08-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020938-001MOBIC7.5MGTABLET / ORALABRLD2000-04-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020938-002MOBIC15MGTABLET / ORALABRLD, RS2000-08-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020938-001MOBIC7.5MGTABLET / ORALABRLD2000-04-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020938-002MOBIC15MGTABLET / ORALABRLD, RS2000-08-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020938-001MOBIC7.5MGTABLET / ORALABRLD2000-04-13782e0a99824c…
2021-12-28 21:50 UTC2021-12N020938-002MOBIC15MGTABLET / ORALABRLD, RS2000-08-23782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020938-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020938-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020938-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020938-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020938-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020938-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020938-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020938-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020938-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020938-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020938-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N020938-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020938-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020938-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020938-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020938-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020938-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020938-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020938-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020938-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020938-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N020938-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020938-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N020938-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020938-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N020938-002AB1ea99ee380514…
2023-12-20 04:57 UTC2023-12N020938-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N020938-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020938-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020938-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020938-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020938-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020938-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020938-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020938-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020938-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020938-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05N020938-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020938-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N020938-002AB13bdfa0b2c4d7…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-618-14EA - Each55289-618b1fb9f9d-4a07-4456-9b65-b7b3efcfa9f312013-02-13
55289-618-30EA - Each55289-6188c15e8e4-bdc2-4dd3-b9a1-97a928af937c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MELOXICAMACTIVE INGREDIENTVG2QF83CGLMOBIC (MELOXICAM) TABLET [PD-RX PHARMACEUTICALS, INC.]9
MELOXICAMACTIVE MOIETYVG2QF83CGLMOBIC (MELOXICAM) TABLET [PD-RX PHARMACEUTICALS, INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMOBIC (MELOXICAM) TABLET [PD-RX PHARMACEUTICALS, INC.]9
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMOBIC (MELOXICAM) TABLET [PD-RX PHARMACEUTICALS, INC.]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMOBIC (MELOXICAM) TABLET [PD-RX PHARMACEUTICALS, INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MOBIC (MELOXICAM) TABLET [PD-RX PHARMACEUTICALS, INC.]9
POVIDONEINACTIVE INGREDIENTFZ989GH94EMOBIC (MELOXICAM) TABLET [PD-RX PHARMACEUTICALS, INC.]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MOBIC (MELOXICAM) TABLET [PD-RX PHARMACEUTICALS, INC.]9
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KMOBIC (MELOXICAM) TABLET [PD-RX PHARMACEUTICALS, INC.]9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-618-145528906181414 TABLET in 1 BOTTLE, PLASTIC (55289-618-14) 14 tablet2012-03-150000-00-00NoNoCurrent