VANCOMYCIN HYDROCHLORIDE

Product NDC
0121-1032
11-digit product format
001211032
Labeler code
0121
Product ID
0121-1032_1db451d1-f9ef-4e0a-8239-1c740369b64e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VANCOMYCIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA065478
Marketing category
ANDA
Marketing start
2026-05-01
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
125 mg/1
Pharmacologic classes
Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VANCOMYCIN HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VANCOMYCIN HYDROCHLORIDE125 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-1032-20VANCOMYCIN HYDROCHLORIDE2 in 1 CARTONCAPSULE21
0121-1032-20VANCOMYCIN HYDROCHLORIDE10 in 1 BLISTER PACKCAPSULE101
0121-1032-50VANCOMYCIN HYDROCHLORIDE50 in 1 BOTTLECAPSULE501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313570vancomycin HCl 125 MG Oral CapsulePSNae6efaaf-37eb-4510-ba71-5f3dc3abdbd31
313571vancomycin HCl 250 MG Oral CapsulePSNae6efaaf-37eb-4510-ba71-5f3dc3abdbd31
313570vancomycin 125 MG Oral CapsuleSCDae6efaaf-37eb-4510-ba71-5f3dc3abdbd31
313571vancomycin 250 MG Oral CapsuleSCDae6efaaf-37eb-4510-ba71-5f3dc3abdbd31
313570vancomycin (as vancomycin hydrochloride) 125 MG Oral CapsuleSYae6efaaf-37eb-4510-ba71-5f3dc3abdbd31
313571vancomycin (as vancomycin hydrochloride) 250 MG Oral CapsuleSYae6efaaf-37eb-4510-ba71-5f3dc3abdbd31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0121-1032-20001211032202 BLISTER PACK in 1 CARTON (0121-1032-20) / 10 CAPSULE in 1 BLISTER PACK2 blister pack2026-05-01NoNoHistorical
0121-1032-500012110325050 CAPSULE in 1 BOTTLE (0121-1032-50) 50 capsule2026-05-01NoNoHistorical