cysteine hydrochloride

Generic: cysteine hydrochloride

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cysteine hydrochloride
Generic Name cysteine hydrochloride
Labeler baxter healthcare corporation
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

cysteine hydrochloride 34.5 mg/mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 0338-9645
Product ID 0338-9645_26874b67-a94f-46fd-82de-0b44b93d3db4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212535
Listing Expiration 2027-12-31
Marketing Start 2022-04-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03389645
Hyphenated Format 0338-9645

Supplemental Identifiers

RxCUI
1667993
UNII
ZT934N0X4W

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cysteine hydrochloride (source: ndc)
Generic Name cysteine hydrochloride (source: ndc)
Application Number NDA212535 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 34.5 mg/mL
source: ndc
Packaging
  • 5 VIAL, SINGLE-DOSE in 1 CARTON (0338-9645-01) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0338-9645-01 5 VIAL, SINGLE-DOSE in 1 CARTON (0338-9645-01) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

cysteine hydrochloride (34.5 mg/mL)

Linked Drug Pages (1)

CYSTEINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "26874b67-a94f-46fd-82de-0b44b93d3db4", "openfda": {"unii": ["ZT934N0X4W"], "rxcui": ["1667993"], "spl_set_id": ["cbf70fc3-14b3-4c17-8de8-acba1e12ac95"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 CARTON (0338-9645-01)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0338-9645-01", "marketing_start_date": "20220429"}], "brand_name": "CYSTEINE HYDROCHLORIDE", "product_id": "0338-9645_26874b67-a94f-46fd-82de-0b44b93d3db4", "dosage_form": "INJECTION", "product_ndc": "0338-9645", "generic_name": "cysteine hydrochloride", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CYSTEINE HYDROCHLORIDE", "active_ingredients": [{"name": "CYSTEINE HYDROCHLORIDE", "strength": "34.5 mg/mL"}], "application_number": "NDA212535", "marketing_category": "NDA", "marketing_start_date": "20220429", "listing_expiration_date": "20271231"}