FDA.reportPublic FDA data

VANCOMYCIN HYDROCHLORIDE

Product NDC
76333-264
11-digit product format
763330264
Labeler code
76333
Product ID
76333-264_e28461cb-fb8f-f468-e053-2a95a90ac294
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VANCOMYCIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Orient Pharma Co.,Ltd Yunlin Plant
Application
ANDA210729
Marketing category
ANDA
Marketing start
2019-07-25
Marketing end
0000-00-00
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
125 mg/1
Pharmacologic classes
Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
518d3e87-1791-43fd-b421-7f508923e5f1Product name420260107
8c6bdc15-c879-407f-914d-b44fce8e7bbdProduct name120240730
324cd4ef-8967-4991-91fd-3046d51874b9Product name220240118
ba2497d8-e8e9-d71b-251e-24ac323bbaa3Product name920231206
01f96903-8ada-4a91-9a58-9f8e51b7a70aProduct name120230922
e5c5573a-2fda-453b-9d65-c6185b588ecdProduct name520220613
3a86dfd0-ed28-4976-b9ec-00923fbfbdd4Product name120220308
5d603187-d384-6e74-5fc7-30310b2b3c99Product name320190717
bec007f0-8cd6-4f79-a3df-c0d94ebb2a36Product name120190614
f4fec0bc-aaaa-4c5c-aa2b-21daf18ef477Product name120160209
a0c54c75-e1f1-eb4f-25c4-be91c2fe237dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76333-264-012024-01-30C16284748780-11030e365-5bea-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VANCOMYCIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for VANCOMYCIN HYDROCHLORIDE CAPSULES. VANCOMYCIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1986 To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules should be used only to treat infections that are prove
76333-264-172024-01-30C16284748780-11030e365-5bea-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VANCOMYCIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for VANCOMYCIN HYDROCHLORIDE CAPSULES. VANCOMYCIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1986 To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules should be used only to treat infections that are prove

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76333-264-01VANCOMYCIN HYDROCHLORIDE2 in 1 CARTONCAPSULE210
76333-264-17VANCOMYCIN HYDROCHLORIDE50 in 1 BOTTLECAPSULE5010
76333-264-26VANCOMYCIN HYDROCHLORIDE10 in 1 BLISTER PACKCAPSULE1010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76333-264VANCOMYCIN HYDROCHLORIDE CAPSULE [ORIENT PHARMA CO.,LTD YUNLIN PLANT]10Legacy NDC, 3 package rows20220630_6d7205eb-dd9f-4a43-91d8-4678293e7159.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313570vancomycin HCl 125 MG Oral CapsulePSN6d7205eb-dd9f-4a43-91d8-4678293e715910
313571vancomycin HCl 250 MG Oral CapsulePSN6d7205eb-dd9f-4a43-91d8-4678293e715910
313570vancomycin 125 MG Oral CapsuleSCD6d7205eb-dd9f-4a43-91d8-4678293e715910
313571vancomycin 250 MG Oral CapsuleSCD6d7205eb-dd9f-4a43-91d8-4678293e715910
313570vancomycin (as vancomycin hydrochloride) 125 MG Oral CapsuleSY6d7205eb-dd9f-4a43-91d8-4678293e715910
313571vancomycin (as vancomycin hydrochloride) 250 MG Oral CapsuleSY6d7205eb-dd9f-4a43-91d8-4678293e715910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76333-264-01763330264012 BLISTER PACK in 1 CARTON (76333-264-01) > 10 CAPSULE in 1 BLISTER PACK (76333-264-26) 2 blister pack2019-07-250000-00-00NoNoCurrent
76333-264-177633302641750 CAPSULE in 1 BOTTLE (76333-264-17) 50 capsule2019-07-250000-00-00NoNoCurrent
76333-264-267633302642610 in 1 BLISTER PACKHistorical