vancomycin hydrochloride

Product NDC
23155-858
11-digit product format
231550858
Labeler code
23155
Product ID
23155-858_2192deb8-3a85-4ecd-9fb3-8c1dd4c5191f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vancomycin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA065490
Marketing category
ANDA
Marketing start
2023-06-25
Marketing end
2028-08-31
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
125 mg/1
Pharmacologic classes
Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
vancomycin hydrochloride

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
23155-858-25vancomycin hydrochloride50 in 1 BOTTLECAPSULE505
23155-858-78vancomycin hydrochloride10 in 1 BLISTER PACKCAPSULE105
23155-858-78vancomycin hydrochloride2 in 1 CARTONCAPSULE25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-858-25EA - Each23155-858dd8cb7ac-69a0-45f5-a75e-08f489bf7e0e12023-09-05
23155-858-78EA - Each23155-858721b8d00-f4a6-4b32-91e5-7741e40f005212023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-858VANCOMYCIN HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]3Current NDC, 3 package rows20250316_ab658fbd-68ea-4275-84b1-c3361c860bd3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313570vancomycin HCl 125 MG Oral CapsulePSNab658fbd-68ea-4275-84b1-c3361c860bd35
313571vancomycin HCl 250 MG Oral CapsulePSNab658fbd-68ea-4275-84b1-c3361c860bd35
313570vancomycin 125 MG Oral CapsuleSCDab658fbd-68ea-4275-84b1-c3361c860bd35
313571vancomycin 250 MG Oral CapsuleSCDab658fbd-68ea-4275-84b1-c3361c860bd35
313570vancomycin (as vancomycin hydrochloride) 125 MG Oral CapsuleSYab658fbd-68ea-4275-84b1-c3361c860bd35
313571vancomycin (as vancomycin hydrochloride) 250 MG Oral CapsuleSYab658fbd-68ea-4275-84b1-c3361c860bd35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-858-252315508582550 CAPSULE in 1 BOTTLE (23155-858-25) 50 capsule2023-06-252028-08-31NoNoHistorical
23155-858-78231550858782 BLISTER PACK in 1 CARTON (23155-858-78) / 10 CAPSULE in 1 BLISTER PACK2 blister pack2023-06-252027-08-31NoNoHistorical