Home NDC 24338-017 BRYNOVIN
Product NDC 24338-017
11-digit product format 243380017
Labeler code 24338
Product ID 24338-017_9468a2f3-3ebe-40bd-a3b4-d78d9eb47e04
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sitagliptin Hydrochloride Oral
Dosage form SOLUTION
Route ORAL
Labeler Azurity Pharmaceuticals, Inc.
Application NDA219122
Marketing category NDA
Marketing start 2025-04-01
Substance SITAGLIPTIN
Active strength 25 mg/mL
Pharmacologic classes Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219122-001 BRYNOVIN SITAGLIPTIN HYDROCHLORIDE EQ 25MG BASE/ML SOLUTION / ORAL RLD, RS 2025-01-16
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219122-001 11944621 2040-10-23 Drug product 2025-02-21 N219122-001 12295953 2040-10-23 Drug product 2025-06-05
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.
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 N219122-001 BRYNOVIN EQ 25MG BASE/ML SOLUTION / ORAL RLD, RS 2025-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219122-001 BRYNOVIN EQ 25MG BASE/ML SOLUTION / ORAL RLD, RS 2025-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219122-001 BRYNOVIN EQ 25MG BASE/ML SOLUTION / ORAL RLD, RS 2025-01-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N219122-001 BRYNOVIN EQ 25MG BASE/ML SOLUTION / ORAL RLD, RS 2025-01-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N219122-001 BRYNOVIN EQ 25MG BASE/ML SOLUTION / ORAL RLD, RS 2025-01-16 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219122-001 BRYNOVIN EQ 25MG BASE/ML SOLUTION / ORAL RLD, RS 2025-01-16 a50c72e98297…
Observed Orange Book patent history# 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 N219122-001 11944621 2040-10-23 Drug product 2025-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219122-001 12295953 2040-10-23 Drug product 2025-06-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219122-001 11944621 2040-10-23 Drug product 2025-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219122-001 12295953 2040-10-23 Drug product 2025-06-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219122-001 11944621 2040-10-23 Drug product 2025-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219122-001 12295953 2040-10-23 Drug product 2025-06-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N219122-001 11944621 2040-10-23 Drug product 2025-02-21 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219122-001 11944621 2040-10-23 Drug product 2025-02-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219122-001 12295953 2040-10-23 Drug product 2025-06-05 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base BRYNOVIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SITAGLIPTIN 25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QFP0P1DV7Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2716485 Internal RxNorm lookup 2716491 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 24338-017-01 BRYNOVIN 120 mL in 1 BOTTLE SOLUTION 120 1 24338-017-01 BRYNOVIN 1 in 1 CARTON SOLUTION 1 1
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BRYNOVIN SITAGLIPTIN HYDROCHLORIDE ORAL Azurity Pharmaceuticals, Inc. 9468a2f3-3ebe-40bd-a3b4-d78d9eb47e04 2025-01-02 Warnings, Adverse reactions Exact identifier application applno (NDA): 219122 application number: NDA219122 ndc (product): 24338-017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 24338-017-01 24338001701 1 BOTTLE in 1 CARTON (24338-017-01) / 120 mL in 1 BOTTLE 1 bottle 2025-04-01 No No Current