FDA.reportPublic FDA data

FIRVANQ

Product NDC
65628-205
11-digit product format
656280205
Labeler code
65628
Product ID
65628-205_4606f496-387d-f0e0-e063-6294a90ad37a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vancomycin hydrochloride
Dosage form
KIT
Labeler
Azurity Pharmaceuticals, Inc
Application
NDA208910
Marketing category
NDA
Marketing start
2018-01-26
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui2000127, 2000133, 2000134, 2000136

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
65628-205-10FIRVANQ1 in 1 CARTONKIT111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65628-205-10ML - Milliliter65628-205df960271-1d4b-40fb-a61b-aaff3fded55b12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65628-205FIRVANQ (VANCOMYCIN HYDROCHLORIDE) KIT [AZURITY PHARMACEUTICALS, INC]10Current NDC, Legacy NDC, 1 package rows20231209_5aca5508-b577-446c-9980-ab4c7582b4b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2000133FIRVANQ 25 MG/mL Oral SolutionPSN5aca5508-b577-446c-9980-ab4c7582b4b911
2000136FIRVANQ 50 MG/mL Oral SolutionPSN5aca5508-b577-446c-9980-ab4c7582b4b911
2000127vancomycin 25 MG/mL Oral SolutionPSN5aca5508-b577-446c-9980-ab4c7582b4b911
2000134vancomycin 50 MG/mL Oral SolutionPSN5aca5508-b577-446c-9980-ab4c7582b4b911
2000133vancomycin 25 MG/ML Oral Solution [Firvanq]SBD5aca5508-b577-446c-9980-ab4c7582b4b911
2000136vancomycin 50 MG/ML Oral Solution [Firvanq]SBD5aca5508-b577-446c-9980-ab4c7582b4b911
2000127vancomycin 25 MG/ML Oral SolutionSCD5aca5508-b577-446c-9980-ab4c7582b4b911
2000134vancomycin 50 MG/ML Oral SolutionSCD5aca5508-b577-446c-9980-ab4c7582b4b911
2000133Firvanq 25 MG/ML Oral SolutionSY5aca5508-b577-446c-9980-ab4c7582b4b911
2000136Firvanq 50 MG/ML Oral SolutionSY5aca5508-b577-446c-9980-ab4c7582b4b911
2000127vancomycin (as vancomycin hydrochloride) 25 MG/ML Oral SolutionSY5aca5508-b577-446c-9980-ab4c7582b4b911
2000134vancomycin (as vancomycin hydrochloride) 50 MG/ML Oral SolutionSY5aca5508-b577-446c-9980-ab4c7582b4b911
2000134vancomycin 15 GM per 289 ML Powder for Oral SolutionSY5aca5508-b577-446c-9980-ab4c7582b4b911
2000134vancomycin 250 MG per 5 ML Powder for Oral SolutionSY5aca5508-b577-446c-9980-ab4c7582b4b911
2000127vancomycin 3.75 GM per 147 ML Powder for Oral SolutionSY5aca5508-b577-446c-9980-ab4c7582b4b911
2000134vancomycin 7.5 GM per 145 ML Powder for Oral SolutionSY5aca5508-b577-446c-9980-ab4c7582b4b911
2000127vancomycin 7.5 GM per 295 ML Powder for Oral SolutionSY5aca5508-b577-446c-9980-ab4c7582b4b911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65628-205-10656280205101 KIT in 1 CARTON (65628-205-10) * 7.5 g in 1 BOTTLE * 295 mL in 1 BOTTLE1 kit2018-01-260000-00-00NoNoCurrent