FDA.reportPublic FDA data

Vancomycin Hydrochloride

Product NDC
42494-450
11-digit product format
424940450
Labeler code
42494
Product ID
42494-450_4f6faa36-cb96-9777-e063-6294a90aa602
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vancomycin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Cameron Pharmaceuticals
Application
ANDA210729
Marketing category
ANDA
Marketing start
2024-01-15
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42494-450-202026-01-29C16284748780-149896155-a365-586f-e063-e6dba90add90These 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
42494-450-502026-01-29C16284748780-149896155-a365-586f-e063-e6dba90add90These 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
42494-450-20Vancomycin Hydrochloride2 in 1 CARTONCAPSULE24
42494-450-20Vancomycin Hydrochloride10 in 1 BLISTER PACKCAPSULE104
42494-450-50Vancomycin Hydrochloride50 in 1 BOTTLE, PLASTICCAPSULE504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42494-450-20EA - Each42494-4504cc3b6bb-e8d5-45c8-93b4-267877b0844d12024-03-12
42494-450-50EA - Each42494-4501c6af43a-ba58-4323-9a3a-4ad95a15404f12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42494-450VANCOMYCIN HYDROCHLORIDE CAPSULE [CAMERON PHARMACEUTICALS]2Current NDC, 3 package rows20240216_bc737938-ae36-460b-a2a8-609f3fe59156.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313570vancomycin HCl 125 MG Oral CapsulePSNd6b8147b-5f93-49ee-8b27-78fe58987c90100
313570vancomycin 125 MG Oral CapsuleSCDd6b8147b-5f93-49ee-8b27-78fe58987c90100
313570vancomycin (as vancomycin hydrochloride) 125 MG Oral CapsuleSYd6b8147b-5f93-49ee-8b27-78fe58987c90100
313570vancomycin HCl 125 MG Oral CapsulePSNbc737938-ae36-460b-a2a8-609f3fe591564
313571vancomycin HCl 250 MG Oral CapsulePSNbc737938-ae36-460b-a2a8-609f3fe591564
313570vancomycin 125 MG Oral CapsuleSCDbc737938-ae36-460b-a2a8-609f3fe591564
313571vancomycin 250 MG Oral CapsuleSCDbc737938-ae36-460b-a2a8-609f3fe591564
313570vancomycin (as vancomycin hydrochloride) 125 MG Oral CapsuleSYbc737938-ae36-460b-a2a8-609f3fe591564
313571vancomycin (as vancomycin hydrochloride) 250 MG Oral CapsuleSYbc737938-ae36-460b-a2a8-609f3fe591564

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42494-450-20424940450202 BLISTER PACK in 1 CARTON (42494-450-20) / 10 CAPSULE in 1 BLISTER PACK2 blister pack2024-01-152026-12-31NoNoHistorical
42494-450-504249404505050 CAPSULE in 1 BOTTLE, PLASTIC (42494-450-50) 50 capsule2024-01-15NoNoHistorical