Nulibry
- Product NDC
- 42358-295
- 11-digit product format
- 423580295
- Labeler code
- 42358
- Product ID
- 42358-295_f2d66860-2840-4060-82ba-5fa50f4724c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fosdenopterin hydrobromide
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sentynl Therapeutics, Inc.
- Application
- NDA214018
- Marketing category
- NDA
- Marketing start
- 2021-03-30
- Substance
- FOSDENOPTERIN HYDROBROMIDE
- Active strength
- 9.5 mg/1
- Pharmacologic classes
- Cyclic Pyranopterin Monophosphate [EPC], Cyclic Pyranopterin Monophosphate [EXT]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nulibry
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FOSDENOPTERIN HYDROBROMIDE | 9.5 mg/1 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42358-295-01 | Nulibry | 1 in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
| 42358-295-01 | Nulibry | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42358-295 | NULIBRY (FOSDENOPTERIN HYDROBROMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SENTYNL THERAPEUTICS, INC.] | 3 | Current NDC, 2 package rows | 20230412_736aeea3-f206-454d-95d0-fd30964e8aab.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42358-295-01 | 42358029501 | 1 VIAL, SINGLE-DOSE in 1 CARTON (42358-295-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | 2023-04-15 | No | No | Historical |