FDA.reportPublic FDA data

MELOXICAM

Product NDC
52959-856
11-digit product format
529590856
Labeler code
52959
Product ID
52959-856_75369598-0e38-7e91-e053-2a91aa0a498d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MELOXICAM
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA077927
Marketing category
ANDA
Marketing start
2015-12-08
Marketing end
0000-00-00
Substance
MELOXICAM
Active strength
8 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bdef11ce-16e2-4690-96a3-597bcf5cc738Product name120260130
f2791553-0b76-42f4-8d49-af3eda072bfbProduct name120251117
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
3e9b4ed6-844c-4725-9d19-cceb5c823572Product name220210903
b21a682e-c765-4e26-9bb2-dbb8c7b38ef7Product name120200623
a428d1db-64d7-4fc3-8d13-832b1e84b683Product name120190201
96649a58-aac8-401c-be00-450b4335f7e7Product name120161116
f0761cb7-8207-3a19-2ca3-ecbb559b04e1Product name220161116
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-856-012020-01-31C16284748780-19d75b9cf-e018-f424-e053-dadaa90a57ce0856-14,15,20,21,30,36,45,60,90,01
52959-856-142020-01-31C16284748780-19d75b9cf-e018-f424-e053-dadaa90a57ce0856-14,15,20,21,30,36,45,60,90,01
52959-856-152020-01-31C16284748780-19d75b9cf-e018-f424-e053-dadaa90a57ce0856-14,15,20,21,30,36,45,60,90,01
52959-856-202020-01-31C16284748780-19d75b9cf-e018-f424-e053-dadaa90a57ce0856-14,15,20,21,30,36,45,60,90,01
52959-856-212020-01-31C16284748780-19d75b9cf-e018-f424-e053-dadaa90a57ce0856-14,15,20,21,30,36,45,60,90,01
52959-856-302020-01-31C16284748780-19d75b9cf-e018-f424-e053-dadaa90a57ce0856-14,15,20,21,30,36,45,60,90,01
52959-856-362020-01-31C16284748780-19d75b9cf-e018-f424-e053-dadaa90a57ce0856-14,15,20,21,30,36,45,60,90,01
52959-856-452020-01-31C16284748780-19d75b9cf-e018-f424-e053-dadaa90a57ce0856-14,15,20,21,30,36,45,60,90,01
52959-856-602020-01-31C16284748780-19d75b9cf-e018-f424-e053-dadaa90a57ce0856-14,15,20,21,30,36,45,60,90,01
52959-856-902020-01-31C16284748780-19d75b9cf-e018-f424-e053-dadaa90a57ce0856-14,15,20,21,30,36,45,60,90,01

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-856-30Trepoxicam-7.530 in 1 BOTTLETABLET307.5 mg12
52959-856-01MELOXICAM120 in 1 BOTTLETABLET1201
52959-856-14MELOXICAM14 in 1 BOTTLETABLET141
52959-856-15MELOXICAM15 in 1 BOTTLETABLET151
52959-856-20MELOXICAM20 in 1 BOTTLETABLET201
52959-856-21MELOXICAM21 in 1 BOTTLETABLET211
52959-856-30MELOXICAM30 in 1 BOTTLETABLET301
52959-856-36MELOXICAM36 in 1 BOTTLETABLET361
52959-856-45MELOXICAM45 in 1 BOTTLETABLET451
52959-856-60MELOXICAM60 in 1 BOTTLETABLET601
52959-856-90MELOXICAM90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-856-01EA - Each52959-856accfc548-425f-4f30-b52b-ff7082f11a0512018-10-11
52959-856-14EA - Each52959-85611cc2755-e0d6-41de-b6c6-bd96c26dea5012018-10-11
52959-856-15EA - Each52959-856bbb131cd-42eb-4367-92c2-6157d056d73d12018-10-11
52959-856-20EA - Each52959-8565f712fb1-a901-422a-8c5e-4e4fea5162f612018-10-11
52959-856-21EA - Each52959-85619046f3d-164d-45ca-b96c-a5cb337f88bb12018-10-11
52959-856-30EA - Each52959-856117f88e5-e545-44c4-9bf3-e463abab8d6812018-10-11
52959-856-45EA - Each52959-856104c4769-8d4a-4585-be9f-387ba3efea2712018-10-11
52959-856-60EA - Each52959-856c0d5a686-2ad2-42f0-9097-dc07d39b872c12018-10-11
52959-856-90EA - Each52959-8562f35e01b-41c2-4676-a5a1-6fece04c5f4b12018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HISTIDINEACTIVE INGREDIENT4QD397987ETREPOXICAM-7.5 (MELOXICAM, HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]12
MELOXICAMACTIVE INGREDIENTVG2QF83CGLTREPOXICAM-7.5 (MELOXICAM, HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]12
HISTIDINEACTIVE MOIETY4QD397987ETREPOXICAM-7.5 (MELOXICAM, HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]12
SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU4TREPOXICAM-7.5 (MELOXICAM, HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTREPOXICAM-7.5 (MELOXICAM, HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]12
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTREPOXICAM-7.5 (MELOXICAM, HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]12
GELATININACTIVE INGREDIENT2G86QN327LTREPOXICAM-7.5 (MELOXICAM, HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]12
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTREPOXICAM-7.5 (MELOXICAM, HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TREPOXICAM-7.5 (MELOXICAM, HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]12
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DTREPOXICAM-7.5 (MELOXICAM, HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]12
POVIDONEINACTIVE INGREDIENTFZ989GH94ETREPOXICAM-7.5 (MELOXICAM, HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]12
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KTREPOXICAM-7.5 (MELOXICAM, HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-856TREPOXICAM-7.5 (MELOXICAM, HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]12Legacy NDC20110812_36780f92-a17f-4133-8f75-7c3769c40584.zip
52959-856MELOXICAM TABLET [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 10 package rows20180926_75369598-0e37-7e91-e053-2a91aa0a498d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311486meloxicam 7.5 MG Oral TabletPSN36780f92-a17f-4133-8f75-7c3769c4058412
152697Mobic 7.5 MG Oral TabletPSN36780f92-a17f-4133-8f75-7c3769c4058412
152697meloxicam 7.5 MG Oral Tablet [Mobic]SBD36780f92-a17f-4133-8f75-7c3769c4058412
311486meloxicam 7.5 MG Oral TabletSCD36780f92-a17f-4133-8f75-7c3769c4058412
152697Mobic 7.5 MG Oral TabletSY36780f92-a17f-4133-8f75-7c3769c4058412
311486meloxicam 7.5 MG Oral TabletPSN75369598-0e37-7e91-e053-2a91aa0a498d1
311486meloxicam 7.5 MG Oral TabletSCD75369598-0e37-7e91-e053-2a91aa0a498d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-856-0152959085601120 in 1 BOTTLEHistorical
52959-856-145295908561414 in 1 BOTTLEHistorical
52959-856-155295908561515 in 1 BOTTLEHistorical
52959-856-205295908562020 in 1 BOTTLEHistorical
52959-856-215295908562121 in 1 BOTTLEHistorical
52959-856-305295908563030 in 1 BOTTLEHistorical
52959-856-365295908563636 in 1 BOTTLEHistorical
52959-856-455295908564545 in 1 BOTTLEHistorical
52959-856-605295908566060 in 1 BOTTLEHistorical
52959-856-905295908569090 in 1 BOTTLEHistorical