FDA.reportPublic FDA data

Dexlido-M Kit

Product NDC
63187-348
11-digit product format
631870348
Labeler code
63187
Product ID
63187-348_fd895819-b7d4-43bd-b804-f7b0722a00e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone Sodium Phosphate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine
Dosage form
KIT
Labeler
Proficient Rx LP
Application
ANDA040491
Marketing category
ANDA
Marketing start
2014-07-25
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
a831e694-3663-4a83-82be-6c309429f750Product name220200608
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63187-348-012020-01-31C16284748780-19d75b9cf-d71e-f424-e053-dadaa90a57ceDexamethasone Sodium Phosphate Injection,USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-820-09Dexlido-M Kit5 mL in 1 POUCHSWAB15 mL70 mL in 100mL1
63187-348-01Dexlido-M Kit1 in 1 CARTONKIT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-348-01EA - Each63187-3480b0e67ae-a4f7-4ca6-9e95-123271ae766012015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bupivacaine HydrochlorideACTIVE INGREDIENT7TQO7W3VT8DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Dexamethasone Sodium PhosphateACTIVE INGREDIENTAI9376Y64PDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Isopropyl AlcoholACTIVE INGREDIENTND2M416302DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41ADEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Povidone-IodineACTIVE INGREDIENT85H0HZU99MDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
BupivacaineACTIVE MOIETYY8335394RODEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
DexamethasoneACTIVE MOIETY7S5I7G3JQLDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
IodineACTIVE MOIETY9679TC07X4DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Isopropyl AlcoholACTIVE MOIETYND2M416302DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
LidocaineACTIVE MOIETY98PI200987DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Nonoxynol-9INACTIVE INGREDIENT48Q180SH9TDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1
WaterINACTIVE INGREDIENT059QF0KO0RDEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-348DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP]1Legacy NDC, 2 package rows20150407_fd895819-b7d4-43bd-b804-f7b0722a00e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSNfd895819-b7d4-43bd-b804-f7b0722a00e91
1812079dexAMETHasone sodium phosphate 10 MG in 1 ML InjectionPSNfd895819-b7d4-43bd-b804-f7b0722a00e91
797544isopropyl alcohol 70 % Medicated PadPSNfd895819-b7d4-43bd-b804-f7b0722a00e91
1737568lidocaine HCl 1 % in 2 ML InjectionPSNfd895819-b7d4-43bd-b804-f7b0722a00e91
1725079Marcaine 0.25 % in 10 ML InjectionPSNfd895819-b7d4-43bd-b804-f7b0722a00e91
797730povidone-iodine 10 % Medicated PadPSNfd895819-b7d4-43bd-b804-f7b0722a00e91
172507910 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Marcaine]SBDfd895819-b7d4-43bd-b804-f7b0722a00e91
18120791 ML dexamethasone phosphate 10 MG/ML InjectionSCDfd895819-b7d4-43bd-b804-f7b0722a00e91
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDfd895819-b7d4-43bd-b804-f7b0722a00e91
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCDfd895819-b7d4-43bd-b804-f7b0722a00e91
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDfd895819-b7d4-43bd-b804-f7b0722a00e91
797730povidone-iodine 100 MG/ML Medicated PadSCDfd895819-b7d4-43bd-b804-f7b0722a00e91
172507910 ML Marcaine 2.5 MG/ML InjectionSYfd895819-b7d4-43bd-b804-f7b0722a00e91
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSYfd895819-b7d4-43bd-b804-f7b0722a00e91
1812079dexamethasone phosphate 10 MG (as dexamethasone sodium phosphate 11 MG) per 1 ML InjectionSYfd895819-b7d4-43bd-b804-f7b0722a00e91
797544isopropyl alcohol 70 % Medicated PadSYfd895819-b7d4-43bd-b804-f7b0722a00e91
797544isopropyl alcohol 70 % Topical ClothSYfd895819-b7d4-43bd-b804-f7b0722a00e91
797544isopropyl alcohol 70 % Topical SwabSYfd895819-b7d4-43bd-b804-f7b0722a00e91
1737568lidocaine HCl 1 % per 2 ML InjectionSYfd895819-b7d4-43bd-b804-f7b0722a00e91
1737568lidocaine HCl 20 MG per 2 ML InjectionSYfd895819-b7d4-43bd-b804-f7b0722a00e91
1725079Marcaine 0.25 % in 10 ML InjectionSYfd895819-b7d4-43bd-b804-f7b0722a00e91
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSYfd895819-b7d4-43bd-b804-f7b0722a00e91
797730povidone-iodine 10 % Medicated PadSYfd895819-b7d4-43bd-b804-f7b0722a00e91
797730povidone-iodine 10 % Medicated SwabstickSYfd895819-b7d4-43bd-b804-f7b0722a00e91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53329-820-09533290820095 mL in 1 POUCH5 mlHistorical
63187-348-01631870348011 in 1 CARTONHistorical