FDA.reportPublic FDA data

vancomycin hydrochloride

Product NDC
64380-730
11-digit product format
643800730
Labeler code
64380
Product ID
64380-730_b988cf6d-9db2-4a1e-94fc-fc799ca8a1af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vancomycin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA065490
Marketing category
ANDA
Marketing start
2026-01-01
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
vancomycin hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VANCOMYCIN HYDROCHLORIDE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii71WO621TJD
Rxcui313570, 313571

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
64380-730-022025-01-17C16284748780-197449f38-c821-f6ea-e053-dbdaa90aa703Vancomycin Hydrochloride Capsules, USP These highlights do not include all the information needed to use vancomycin hydrochloride capsules, USP safely and effectively. See full prescribing information for vancomycin hydrochloride capsules, USP. Initial U.S. Approval: 1986
64380-730-022019-11-13C16284748780-197449f38-c821-f6ea-e053-dbdaa90aa703Vancomycin Hydrochloride Capsules, USP These highlights do not include all the information needed to use vancomycin hydrochloride capsules, USP safely and effectively. See full prescribing information for vancomycin hydrochloride capsules, USP. Initial U.S. Approval: 1986

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-730-01vancomycin hydrochloride10 in 1 BLISTER PACKCAPSULE103
64380-730-02vancomycin hydrochloride2 in 1 CARTONCAPSULE23
64380-730-03vancomycin hydrochloride50 in 1 BOTTLECAPSULE503
64380-730-04vancomycin hydrochloride100 in 1 BOTTLECAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-730-01EA - Each64380-730bdd2de35-c30d-451f-80c4-e139f3239b0512026-02-05
64380-730-02EA - Each64380-73062109e6a-52ab-48f5-acdf-24f6c9f42e4012026-02-05
64380-730-03EA - Each64380-7304c1be2ff-60a8-49dc-b4d7-e2a4a6b2660212026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313570vancomycin HCl 125 MG Oral CapsulePSNfac438bd-e08f-438d-ab64-426fc5c5450e3
313571vancomycin HCl 250 MG Oral CapsulePSNfac438bd-e08f-438d-ab64-426fc5c5450e3
313570vancomycin 125 MG Oral CapsuleSCDfac438bd-e08f-438d-ab64-426fc5c5450e3
313571vancomycin 250 MG Oral CapsuleSCDfac438bd-e08f-438d-ab64-426fc5c5450e3
313570vancomycin (as vancomycin hydrochloride) 125 MG Oral CapsuleSYfac438bd-e08f-438d-ab64-426fc5c5450e3
313571vancomycin (as vancomycin hydrochloride) 250 MG Oral CapsuleSYfac438bd-e08f-438d-ab64-426fc5c5450e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64380-730-016438007300110 in 1 BLISTER PACKHistorical
64380-730-02643800730022 BLISTER PACK in 1 CARTON (64380-730-02) / 10 CAPSULE in 1 BLISTER PACK (64380-730-01) 2 blister pack2026-01-01NoNoHistorical
64380-730-036438007300350 CAPSULE in 1 BOTTLE (64380-730-03) 50 capsule2026-01-01NoNoHistorical
64380-730-0464380073004100 CAPSULE in 1 BOTTLE (64380-730-04) 100 capsule2026-01-01NoNoHistorical