What is NDC 0641-6228?

0641-6228 is the product NDC for Thiamine Hydrochloride, Thiamine hydrochloride 100 mg/mL injection, solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0641. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Thiamine Hydrochloride?

15 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Thiamine Hydrochloride NDC 0641-6228

NDC codes

FDA NDC Directory

Product NDC (as listed)0641-6228Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00641-6228Add 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
0641-6228-25	0064162282500641622825	25 VIAL in 1 CARTON (0641-6228-25) / 2 mL in 1 VIAL (0641-6228-01)Marketed from Feb 12, 2021

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): Thiamine Hydrochloride
Generic name (nonproprietary): thiamine hydrochloride
Active ingredients: Thiamine hydrochloride — 100 mg/mL
Dosage form: Injection, Solution
Route: Intramuscular, Intravenous
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0641
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 080575
Marketing start: Feb 12, 2021
Listing expires: Dec 31, 2026
Identifiers: Product ID 0641-6228_54a057cd-6e3d-40e6-8329-98e47da7dd68SPL ID 54a057cd-6e3d-40e6-8329-98e47da7dd68SPL set ID 63f3631b-ba1e-430c-a30b-dd05b2c00c13RxCUI 313324UNII M572600E5P

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

N400641622825 followed by a unit qualifier and the quantity

Package 00641-6228-25. 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 11, 2024.

Indications (excerpt from the label)

INDICATIONS Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in Wernicke’s encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. It is also indicated when giving IV dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure. Thiamine hydrochloride injection is also indicated i…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0641-6228

What is NDC 0641-6228?: 0641-6228 is the product NDC for Thiamine Hydrochloride, Thiamine hydrochloride 100 mg/mL injection, solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Thiamine Hydrochloride.
What is the active ingredient?: Thiamine hydrochloride.
Who is the labeler?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0641. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Thiamine Hydrochloride?: 15 other product NDCs are listed under this name. See all Thiamine Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Thiamine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Thiamine Hydrochloride	Thiamine hydrochloride 100 mg/mL	Injection, SolutionIntramuscular, Intravenous	NorthStar RxLLC	72603-565	72603-0565-25
Thiamine Hydrochloride	Thiamine hydrochloride 100 mg/mL	Injection, SolutionIntramuscular, Intravenous	Lifestar Pharma LLC	70756-684	70756-0684-25
Thiamine Hydrochloride	Thiamine hydrochloride 100 mg/mL	Injection, SolutionIntramuscular, Intravenous	Meitheal Pharmaceuticals Inc.	71288-804	71288-0804-03
Thiamine Hydrochloride	Thiamine hydrochloride 100 mg/mL	Injection, SolutionIntramuscular, Intravenous	ONESOURCE SPECIALTY PHARMA LIMITED	83270-004	83270-0004-03
Thiamine Hydrochloride	Thiamine hydrochloride 100 mg/mL	Injection, SolutionIntramuscular, Intravenous	Fosun Pharma USA Inc.	72266-260	72266-0260-25
Thiamine Hydrochloride	Thiamine hydrochloride 100 mg/mL	Injection, SolutionIntramuscular, Intravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-933	23155-0933-41
thiamine hydrochloride	Thiamine hydrochloride 200 mg/2mL	Injection, SolutionIntramuscular, Intravenous	Gland Pharma Limited	68083-567	68083-0567-25
Thiamine Hydrochloride	Thiamine hydrochloride 100 mg/mL	Injection, SolutionIntramuscular, Intravenous	REMEDYREPACK INC.	70518-4230	70518-4230-00
Thiamine Hydrochloride	Thiamine hydrochloride 100 mg/mL	Injection, SolutionIntramuscular, Intravenous	Camber Pharmaceuticals, Inc.	31722-363	31722-0363-32
Thiamine Hydrochloride	Thiamine hydrochloride 100 mg/mL	Injection, SolutionIntramuscular, Intravenous	Henry Schein, Inc.	0404-9799	00404-9799-20

All 16 Thiamine Hydrochloride NDCs

Other NDCs under ANDA 080575

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 080575
Product	Strength	Form · route	Labeler	Product NDC
Thiamine Hydrochloride	Thiamine hydrochloride 100 mg/mL	Injection, SolutionIntramuscular, Intravenous	REMEDYREPACK INC.	70518-4230