FDA.reportPublic FDA data

Marbeta L Kit

Product NDC
76420-782
Requested package NDC
76420-782-01
11-digit product format
764200782
Labeler code
76420
Product ID
76420-782_47db17be-5163-7575-e063-6294a90a923a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Sodium Phosphate, Betamethasone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Isopropyl Alcohol
Dosage form
KIT
Route
EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; TOPICAL
Labeler
Asclemed USA, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2010-04-28
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Marbeta L Kit
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
578803Internal RxNorm lookup
797544Internal RxNorm lookup
797730Internal RxNorm lookup
1725078Internal RxNorm lookup
1737566Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9a6a3871-4e02-47f9-a20e-a256b3f3c498Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
6f762601-17ef-4321-8f47-77783d3c4d8bProduct name320231116
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
1dbefad7-ab34-69c3-e51a-e7148aa38f70Product name520220921
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
a831e694-3663-4a83-82be-6c309429f750Product name220200608
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
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
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
4ea9e4b5-b452-48ad-9b25-b9a4d403405dProduct name120160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-0720-01Marbeta L Kit1 in 1 CARTONINJECTION, SUSPENSION3 mg in 1mL12
0517-0720-01Marbeta L Kit5 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION5 mL3 mg in 1mL12
76420-782-01Marbeta L Kit1 in 1 CARTONKIT112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-782-01EA - Each76420-7825a183674-dfb1-46cd-b825-0be0689cd76812015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Betamethasone AcetateACTIVE INGREDIENTTI05AO53L7MARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]2
Betamethasone Sodium PhosphateACTIVE INGREDIENT7BK02SCL3WMARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]2
Bupivacaine HydrochlorideACTIVE INGREDIENT7TQO7W3VT8MARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]2
Isopropyl AlcoholACTIVE INGREDIENTND2M416302MARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]2
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41AMARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]2
Povidone-IodineACTIVE INGREDIENT85H0HZU99MMARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]2
BetamethasoneACTIVE MOIETY9842X06Q6MMARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]2
BupivacaineACTIVE MOIETYY8335394ROMARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]2
IodineACTIVE MOIETY9679TC07X4MARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]2
Isopropyl AlcoholACTIVE MOIETYND2M416302MARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]2
LidocaineACTIVE MOIETY98PI200987MARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]2
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7MARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]2
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KMARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]2
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBMARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]2
Nonoxynol-9INACTIVE INGREDIENT48Q180SH9TMARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XMARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IMARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]2
Sodium Phosphate, Dibasic AnhydrousINACTIVE INGREDIENT22ADO53M6FMARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]2
Sodium Phosphate, Monobasic, MonohydrateINACTIVE INGREDIENT593YOG76RNMARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RMARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-782MARBETA L KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]11Current NDC, Legacy NDC, 3 package rows20241008_9a6a3871-4e02-47f9-a20e-a256b3f3c498.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Marbeta L KitBETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOLAsclemed USA, Inc.9a6a3871-4e02-47f9-a20e-a256b3f3c4982026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 76420-782-01
ndc (product): 76420-782
ndc11 (package): 76420078201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
578803betamethasone sodium phosphate / betamethasone acetate 6 MG/ML Injectable SuspensionPSN9a6a3871-4e02-47f9-a20e-a256b3f3c49812
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSN9a6a3871-4e02-47f9-a20e-a256b3f3c49812
797544isopropyl alcohol 70 % Medicated PadPSN9a6a3871-4e02-47f9-a20e-a256b3f3c49812
1737566lidocaine HCl 1 % in 5 ML InjectionPSN9a6a3871-4e02-47f9-a20e-a256b3f3c49812
797730povidone-iodine 10 % Medicated PadPSN9a6a3871-4e02-47f9-a20e-a256b3f3c49812
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD9a6a3871-4e02-47f9-a20e-a256b3f3c49812
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCD9a6a3871-4e02-47f9-a20e-a256b3f3c49812
578803betamethasone 3 MG/ML / betamethasone acetate 3 MG/ML Injectable SuspensionSCD9a6a3871-4e02-47f9-a20e-a256b3f3c49812
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD9a6a3871-4e02-47f9-a20e-a256b3f3c49812
797730povidone-iodine 100 MG/ML Medicated PadSCD9a6a3871-4e02-47f9-a20e-a256b3f3c49812
578803betamethasone 3 MG/ML (as betamethasone sodium phosphate) / betamethasone acetate 3 MG/ML Injectable SuspensionSY9a6a3871-4e02-47f9-a20e-a256b3f3c49812
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSY9a6a3871-4e02-47f9-a20e-a256b3f3c49812
797544isopropyl alcohol 70 % Medicated PadSY9a6a3871-4e02-47f9-a20e-a256b3f3c49812
797544isopropyl alcohol 70 % Topical ClothSY9a6a3871-4e02-47f9-a20e-a256b3f3c49812
797544isopropyl alcohol 70 % Topical SwabSY9a6a3871-4e02-47f9-a20e-a256b3f3c49812
1737566lidocaine HCl 1 % per 5 ML InjectionSY9a6a3871-4e02-47f9-a20e-a256b3f3c49812
1737566lidocaine HCl 50 MG per 5 ML InjectionSY9a6a3871-4e02-47f9-a20e-a256b3f3c49812
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY9a6a3871-4e02-47f9-a20e-a256b3f3c49812
797730povidone-iodine 10 % Medicated PadSY9a6a3871-4e02-47f9-a20e-a256b3f3c49812
797730povidone-iodine 10 % Medicated SwabstickSY9a6a3871-4e02-47f9-a20e-a256b3f3c49812
578803betamethasone sodium phosphate / betamethasone acetate 6 MG/ML Injectable SuspensionPSN369a6210-907f-3126-e063-6394a90a0d8f1
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSN369a6210-907f-3126-e063-6394a90a0d8f1
797544isopropyl alcohol 70 % Medicated PadPSN369a6210-907f-3126-e063-6394a90a0d8f1
1737566lidocaine HCl 1 % in 5 ML InjectionPSN369a6210-907f-3126-e063-6394a90a0d8f1
797730povidone-iodine 10 % Medicated PadPSN369a6210-907f-3126-e063-6394a90a0d8f1
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD369a6210-907f-3126-e063-6394a90a0d8f1
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCD369a6210-907f-3126-e063-6394a90a0d8f1
578803betamethasone 3 MG/ML / betamethasone acetate 3 MG/ML Injectable SuspensionSCD369a6210-907f-3126-e063-6394a90a0d8f1
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD369a6210-907f-3126-e063-6394a90a0d8f1
797730povidone-iodine 100 MG/ML Medicated PadSCD369a6210-907f-3126-e063-6394a90a0d8f1
578803betamethasone 3 MG/ML (as betamethasone sodium phosphate) / betamethasone acetate 3 MG/ML Injectable SuspensionSY369a6210-907f-3126-e063-6394a90a0d8f1
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSY369a6210-907f-3126-e063-6394a90a0d8f1
797544isopropyl alcohol 70 % Medicated PadSY369a6210-907f-3126-e063-6394a90a0d8f1
797544isopropyl alcohol 70 % Topical ClothSY369a6210-907f-3126-e063-6394a90a0d8f1
797544isopropyl alcohol 70 % Topical SwabSY369a6210-907f-3126-e063-6394a90a0d8f1
1737566lidocaine HCl 1 % per 5 ML InjectionSY369a6210-907f-3126-e063-6394a90a0d8f1
1737566lidocaine HCl 50 MG per 5 ML InjectionSY369a6210-907f-3126-e063-6394a90a0d8f1
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY369a6210-907f-3126-e063-6394a90a0d8f1
797730povidone-iodine 10 % Medicated PadSY369a6210-907f-3126-e063-6394a90a0d8f1
797730povidone-iodine 10 % Medicated SwabstickSY369a6210-907f-3126-e063-6394a90a0d8f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-782-01764200782011 KIT in 1 CARTON (76420-782-01) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18) * .9 mL in 1 PACKET (67777-419-02) * 5 mL in 1 POUCH * 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-162-05) / 5 mL in 1 VIAL, SINGLE-DOSE * 1 VIAL, MULTI-DOSE in 1 CARTON (0517-0720-01) / 5 mL in 1 VIAL, MULTI-DOSE1 kit2016-05-230000-00-00NoNoCurrent