Nouress
- Product NDC
- 76014-006
- 11-digit product format
- 760140006
- Labeler code
- 76014
- Product ID
- 76014-006_c52947e7-f655-4f78-844c-5b24edaa5fce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cysteine hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Avadel Legacy Pharmaceuticals, LLC
- Application
- NDA212535
- Marketing category
- NDA
- Marketing start
- 2020-04-01
- Marketing end
- 0000-00-00
- Substance
- CYSTEINE HYDROCHLORIDE
- Active strength
- 35 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76014-006-05 | Nouress | 5 in 1 CARTON | INJECTION | 5 | | 1 |
| 76014-006-33 | Nouress | 10 mL in 1 VIAL, SINGLE-USE | INJECTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76014-006 | NOURESS (CYSTEINE HYDROCHLORIDE) INJECTION [AVADEL LEGACY PHARMACEUTICALS, LLC] | 1 | Legacy NDC, 2 package rows | 20200401_627cc059-4124-49b3-a3d3-2eb3ed918bc7.zip |
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 |
|---|
| 76014-006-05 | 76014000605 | 5 VIAL, SINGLE-USE in 1 CARTON (76014-006-05) > 10 mL in 1 VIAL, SINGLE-USE (76014-006-33) | | 2020-04-01 | 0000-00-00 | No | No | Current |
| 76014-006-33 | 76014000633 | 10 mL in 1 VIAL, SINGLE-USE | 10 ml | | | | | Historical |