What is NDC 0338-9645?

0338-9645 is the product NDC for Cysteine Hydrochloride, Cysteine hydrochloride 34.5 mg/mL injection, listed with the FDA by Baxter Healthcare Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.

Baxter Healthcare Corporation, NDC labeler code 0338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cysteine Hydrochloride?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cysteine Hydrochloride NDC 0338-9645

NDC codes

FDA NDC Directory

Product NDC (as listed)0338-9645Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00338-9645Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0338-9645-01	0033896450100338964501	5 VIAL, SINGLE-DOSE in 1 CARTON (0338-9645-01) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Apr 29, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Cysteine Hydrochloride
Generic name (nonproprietary): cysteine hydrochloride
Active ingredients: Cysteine hydrochloride — 34.5 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Baxter Healthcare CorporationNDC labeler code 0338
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 212535
Marketing start: Apr 29, 2022
Listing expires: Dec 31, 2027
Identifiers: Product ID 0338-9645_26874b67-a94f-46fd-82de-0b44b93d3db4SPL ID 26874b67-a94f-46fd-82de-0b44b93d3db4SPL set ID cbf70fc3-14b3-4c17-8de8-acba1e12ac95RxCUI 1667993UNII ZT934N0X4W

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400338964501 followed by a unit qualifier and the quantity

Package 00338-9645-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Apr 29, 2022.

Indications (excerpt from the label)

Cysteine hydrochloride injection, USP is indicated for use as an additive to amino acids solutions to meet nutritional requirements of neonates (preterm and term infants less than one month of age) requiring total parenteral nutrition. Cysteine hydrochloride injection, USP is a sulfur-containing amino acid indicated for use as an additive to amino acids solutions to meet nutritional requirements of neonates (preterm and term infants less than one month of age) requiring total parenteral nutrition. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0338-9645

What is NDC 0338-9645?: 0338-9645 is the product NDC for Cysteine Hydrochloride, Cysteine hydrochloride 34.5 mg/mL injection, listed with the FDA by Baxter Healthcare Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cysteine Hydrochloride.
What is the active ingredient?: Cysteine hydrochloride.
Who is the labeler?: Baxter Healthcare Corporation, NDC labeler code 0338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cysteine Hydrochloride?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.