CYSTEINE HYDROCHLORIDE
- Product NDC
- 0338-9645
- 11-digit product format
- 003389645
- Labeler code
- 0338
- Product ID
- 0338-9645_26874b67-a94f-46fd-82de-0b44b93d3db4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cysteine hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Baxter Healthcare Corporation
- Application
- NDA212535
- Marketing category
- NDA
- Marketing start
- 2022-04-29
- Substance
- CYSTEINE HYDROCHLORIDE
- Active strength
- 34.5 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CYSTEINE HYDROCHLORIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYSTEINE HYDROCHLORIDE | 34.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ZT934N0X4W |
| Rxcui | 1667993 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0338-9645-01 | CYSTEINE HYDROCHLORIDE | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | | 5 |
| 0338-9645-01 | CYSTEINE HYDROCHLORIDE | 5 in 1 CARTON | INJECTION | 5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0338-9645 | CYSTEINE HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250315_cbf70fc3-14b3-4c17-8de8-acba1e12ac95.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0338-9645-01 | 00338964501 | 5 VIAL, SINGLE-DOSE in 1 CARTON (0338-9645-01) / 10 mL in 1 VIAL, SINGLE-DOSE | 2022-04-29 | 0000-00-00 | No | No | Current |