Home NDC 65628-205 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208910-001 FIRVANQ KIT VANCOMYCIN HYDROCHLORIDE EQ 25MG BASE/ML FOR SOLUTION / ORAL AA RLD, RS 2018-01-26 N208910-002 FIRVANQ KIT VANCOMYCIN HYDROCHLORIDE EQ 50MG BASE/ML FOR SOLUTION / ORAL AA RLD, RS 2018-01-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 20 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208910-001 10493028 2035-03-13 Drug product 2019-12-05 N208910-001 10688046 2035-03-13 Drug product 2020-07-10 N208910-001 10959946 2035-03-13 Drug product 2021-04-15 N208910-001 10959947 2035-03-13 U-3104 Drug product 2021-04-15 N208910-001 10959947 2035-03-13 U-3105 Drug product 2021-04-15 N208910-001 10959948 2035-03-13 U-3104 Drug product 2021-04-15 N208910-001 10959948 2035-03-13 U-3105 Drug product 2021-04-15 N208910-001 10959949 2035-03-13 U-3104 Drug product 2021-04-15 N208910-001 10959949 2035-03-13 U-3105 Drug product 2021-04-15 N208910-001 11638692 2035-03-13 Drug product 2023-05-02 N208910-002 10493028 2035-03-13 Drug product 2019-12-05 N208910-002 10688046 2035-03-13 Drug product 2020-07-10 N208910-002 10959946 2035-03-13 Drug product 2021-04-15 N208910-002 10959947 2035-03-13 U-3104 Drug product 2021-04-15 N208910-002 10959947 2035-03-13 U-3105 Drug product 2021-04-15 N208910-002 10959948 2035-03-13 U-3104 Drug product 2021-04-15 N208910-002 10959948 2035-03-13 U-3105 Drug product 2021-04-15 N208910-002 10959949 2035-03-13 U-3104 Drug product 2021-04-15 N208910-002 10959949 2035-03-13 U-3105 Drug product 2021-04-15 N208910-002 11638692 2035-03-13 Drug product 2023-05-02
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208910-001 FIRVANQ KIT EQ 25MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208910-002 FIRVANQ KIT EQ 50MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208910-001 FIRVANQ KIT EQ 25MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208910-002 FIRVANQ KIT EQ 50MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208910-001 FIRVANQ KIT EQ 25MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208910-002 FIRVANQ KIT EQ 50MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208910-001 FIRVANQ KIT EQ 25MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208910-002 FIRVANQ KIT EQ 50MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208910-001 FIRVANQ KIT EQ 25MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208910-002 FIRVANQ KIT EQ 50MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208910-001 FIRVANQ KIT EQ 25MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208910-002 FIRVANQ KIT EQ 50MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208910-001 FIRVANQ KIT EQ 25MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208910-002 FIRVANQ KIT EQ 50MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208910-001 FIRVANQ KIT EQ 25MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208910-002 FIRVANQ KIT EQ 50MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208910-001 FIRVANQ KIT EQ 25MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208910-002 FIRVANQ KIT EQ 50MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208910-001 FIRVANQ KIT EQ 25MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208910-002 FIRVANQ KIT EQ 50MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208910-001 FIRVANQ KIT EQ 25MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208910-002 FIRVANQ KIT EQ 50MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208910-001 FIRVANQ KIT EQ 25MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208910-002 FIRVANQ KIT EQ 50MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208910-001 FIRVANQ KIT EQ 25MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208910-002 FIRVANQ KIT EQ 50MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208910-001 FIRVANQ KIT EQ 25MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N208910-002 FIRVANQ KIT EQ 50MG BASE/ML FOR SOLUTION / ORAL AB RLD, RS 2018-01-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208910-001 FIRVANQ KIT EQ 25MG BASE/ML FOR SOLUTION / ORAL RLD, RS 2018-01-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208910-002 FIRVANQ KIT EQ 50MG BASE/ML FOR SOLUTION / ORAL RLD, RS 2018-01-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208910-001 FIRVANQ KIT EQ 25MG BASE/ML FOR SOLUTION / ORAL RLD, RS 2018-01-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N208910-002 FIRVANQ KIT EQ 50MG BASE/ML FOR SOLUTION / ORAL RLD, RS 2018-01-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208910-001 FIRVANQ KIT EQ 25MG BASE/ML FOR SOLUTION / ORAL RLD, RS 2018-01-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N208910-002 FIRVANQ KIT EQ 50MG BASE/ML FOR SOLUTION / ORAL RLD, RS 2018-01-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208910-001 FIRVANQ KIT EQ 25MG BASE/ML FOR SOLUTION / ORAL RLD, RS 2018-01-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208910-002 FIRVANQ KIT EQ 50MG BASE/ML FOR SOLUTION / ORAL RLD, RS 2018-01-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208910-001 FIRVANQ KIT EQ 25MG BASE/ML FOR SOLUTION / ORAL RLD, RS 2018-01-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N208910-002 FIRVANQ KIT EQ 50MG BASE/ML FOR SOLUTION / ORAL RLD, RS 2018-01-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208910-001 FIRVANQ KIT EQ 25MG BASE/ML FOR SOLUTION / ORAL RLD, RS 2018-01-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N208910-002 FIRVANQ KIT EQ 50MG BASE/ML FOR SOLUTION / ORAL RLD, RS 2018-01-26 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
Observed Orange Book patent history# Patent history page 1 of 17 · 656 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208910-001 10493028 2035-03-13 Drug product 2019-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208910-001 10688046 2035-03-13 Drug product 2020-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208910-001 10959946 2035-03-13 Drug product 2021-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208910-001 10959947 2035-03-13 U-3105 Drug product 2021-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208910-001 10959947 2035-03-13 U-3104 Drug product 2021-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208910-001 10959948 2035-03-13 U-3105 Drug product 2021-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208910-001 10959948 2035-03-13 U-3104 Drug product 2021-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208910-001 10959949 2035-03-13 U-3104 Drug product 2021-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208910-001 10959949 2035-03-13 U-3105 Drug product 2021-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208910-001 11638692 2035-03-13 Drug product 2023-05-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208910-002 10493028 2035-03-13 Drug product 2019-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208910-002 10688046 2035-03-13 Drug product 2020-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208910-002 10959946 2035-03-13 Drug product 2021-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208910-002 10959947 2035-03-13 U-3104 Drug product 2021-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208910-002 10959947 2035-03-13 U-3105 Drug product 2021-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208910-002 10959948 2035-03-13 U-3104 Drug product 2021-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208910-002 10959948 2035-03-13 U-3105 Drug product 2021-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208910-002 10959949 2035-03-13 U-3105 Drug product 2021-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208910-002 10959949 2035-03-13 U-3104 Drug product 2021-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208910-002 11638692 2035-03-13 Drug product 2023-05-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208910-001 10493028 2035-03-13 Drug product 2019-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208910-001 10688046 2035-03-13 Drug product 2020-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208910-001 10959946 2035-03-13 Drug product 2021-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208910-001 10959947 2035-03-13 U-3105 Drug product 2021-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208910-001 10959947 2035-03-13 U-3104 Drug product 2021-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208910-001 10959948 2035-03-13 U-3105 Drug product 2021-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208910-001 10959948 2035-03-13 U-3104 Drug product 2021-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208910-001 10959949 2035-03-13 U-3104 Drug product 2021-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208910-001 10959949 2035-03-13 U-3105 Drug product 2021-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208910-001 11638692 2035-03-13 Drug product 2023-05-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208910-002 10493028 2035-03-13 Drug product 2019-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208910-002 10688046 2035-03-13 Drug product 2020-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208910-002 10959946 2035-03-13 Drug product 2021-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208910-002 10959947 2035-03-13 U-3104 Drug product 2021-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208910-002 10959947 2035-03-13 U-3105 Drug product 2021-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208910-002 10959948 2035-03-13 U-3104 Drug product 2021-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208910-002 10959948 2035-03-13 U-3105 Drug product 2021-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208910-002 10959949 2035-03-13 U-3105 Drug product 2021-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208910-002 10959949 2035-03-13 U-3104 Drug product 2021-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208910-002 11638692 2035-03-13 Drug product 2023-05-02 31067a03dcf5…
Additional Listing Data#
Finished product Yes
Brand name base FIRVANQ
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2000127 Internal RxNorm lookup 2000133 Internal RxNorm lookup 2000134 Internal RxNorm lookup 2000136 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65628-205-10 FIRVANQ 1 in 1 CARTON KIT 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65628-205 FIRVANQ (VANCOMYCIN HYDROCHLORIDE) KIT [AZURITY PHARMACEUTICALS, INC] 10 Current NDC, Legacy NDC, 1 package rows 20231209_5aca5508-b577-446c-9980-ab4c7582b4b9.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65628-205-10 65628020510 1 KIT in 1 CARTON (65628-205-10) * 7.5 g in 1 BOTTLE * 295 mL in 1 BOTTLE 1 kit 2018-01-26 0000-00-00 No No Current