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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BRYNOVIN
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SITAGLIPTIN | 25 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | QFP0P1DV7Z |
| Rxcui | 2716485, 2716491 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 19a549d9-1cb9-4833-ba02-91db3dcb07ba | Product name | 1 | 20251107 |
| f6d21fb1-2c09-48ab-8d89-eeadf5a9698e | Product name | 1 | 20250724 |
| ff2e6e82-af62-4b84-b1ca-09520f6c5a79 | Product name | 1 | 20250630 |
| 25bfaa4d-02a1-402c-96ec-9bf6e625484c | Product name | 1 | 20250307 |
| fd232072-39c4-4416-9b66-265d18a7bd93 | Product name | 1 | 20180306 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 25391a6f-d1ba-6bff-d36e-050dc68ef0e6 | Product name | 1 | 20140508 |
| 2de6e143-c970-2061-1b77-61c3aa8f4026 | Product name | 1 | 20140508 |
| 9fa860f8-41a8-caa8-93ae-a5bdc7b15db7 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 24338-017-01 | ML - Milliliter | 24338-017 | 7a04b052-0bad-4bac-94b4-a44461361e57 | 1 | 2025-07-08 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2716491 | Brynovin 25 MG/mL Oral Solution | PSN | 9468a2f3-3ebe-40bd-a3b4-d78d9eb47e04 | 1 |
| 2716485 | SITagliptin 25 MG/mL Oral Solution | PSN | 9468a2f3-3ebe-40bd-a3b4-d78d9eb47e04 | 1 |
| 2716491 | sitagliptin 25 MG/ML Oral Solution [Brynovin] | SBD | 9468a2f3-3ebe-40bd-a3b4-d78d9eb47e04 | 1 |
| 2716485 | sitagliptin 25 MG/ML Oral Solution | SCD | 9468a2f3-3ebe-40bd-a3b4-d78d9eb47e04 | 1 |
| 2716491 | Brynovin 25 MG per 1 mL Oral Solution | SY | 9468a2f3-3ebe-40bd-a3b4-d78d9eb47e04 | 1 |
| 2716491 | Brynovin 25 MG/ML Oral Solution | SY | 9468a2f3-3ebe-40bd-a3b4-d78d9eb47e04 | 1 |
| 2716485 | sitagliptin 25 MG (as sitagliptin HCl) per 1 mL Oral Solution | SY | 9468a2f3-3ebe-40bd-a3b4-d78d9eb47e04 | 1 |
Packages#
| 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 |