What is NDC 0641-6263?

0641-6263 is the product NDC for Sodium Acetate, Sodium acetate anhydrous 164 mg/mL injection, 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 Sodium Acetate?

12 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sodium Acetate NDC 0641-6263 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0641-6263Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00641-6263Add 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
0641-6263-10	0064162631000641626310	10 VIAL in 1 CARTON (0641-6263-10) / 100 mL in 1 VIAL (0641-6263-01)Marketed from May 20, 2024

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): Sodium Acetate
Generic name (nonproprietary): sodium acetate
Active ingredients: Sodium acetate anhydrous — 164 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0641
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216920
Marketing start: May 20, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)
Identifiers: Product ID 0641-6263_777b7564-f07b-401a-a042-0cd512ae3b25SPL ID 777b7564-f07b-401a-a042-0cd512ae3b25SPL set ID 7ee23a1c-bc99-4ff6-b2e7-d2aa42744553RxCUI 237371UNII NVG71ZZ7P0
Pharmacologic class: Osmotic Laxative

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

N400641626310 followed by a unit qualifier and the quantity

Package 00641-6263-10. 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 May 8, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Sodium acetate injection (2 mEq/mL) is indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0641-6263

What is NDC 0641-6263?: 0641-6263 is the product NDC for Sodium Acetate, Sodium acetate anhydrous 164 mg/mL injection, 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?: Sodium Acetate.
What is the active ingredient?: Sodium acetate anhydrous.
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 Sodium Acetate?: 12 other product NDCs are listed under this name. See all Sodium Acetate 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 Sodium Acetate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sodium Acetate	Sodium acetate anhydrous 164 mg/mL	Injection, Solution, ConcentrateIntravenous	Amneal Pharmaceuticals Private Limited	80830-2435	80830-2435-02
Sodium Acetate	Sodium acetate anhydrous 164 mg/mL	Injection, Solution, ConcentrateIntravenous	Amneal Pharmaceuticals Private Limited	80830-2436	80830-2436-02
Sodium Acetate	Sodium acetate anhydrous 164 mg/mL	Injection, Solution, ConcentrateIntravenous	Amneal Pharmaceuticals Private Limited	80830-2437	80830-2437-02
Sodium Acetate	Sodium acetate 164 mg/mL	Injection, Solution, ConcentrateIntravenous	MILLA PHARMACEUTICALS INC.	71357-002	71357-0002-10
Sodium Acetatesodium acetate injection, usp, 400 meq/100 ml	Sodium acetate 400 meq/100mL	Injection, Solution, ConcentrateIntravenous	MILLA PHARMACEUTICALS INC.	71357-009	71357-0009-10
Sodium Acetate	Sodium acetate 164 mg/mL	Injection, Solution, ConcentrateIntravenous	MILLA PHARMACEUTICALS INC.	71357-007	71357-0007-10
Sodium Acetatesodium acetate injection, usp, 200 meq/100 ml	Sodium acetate 200 meq/100mL	Injection, Solution, ConcentrateIntravenous	MILLA PHARMACEUTICALS INC.	71357-008	71357-0008-10
Sodium Acetate	Sodium acetate anhydrous 164 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0641-6261	00641-6261-01
Sodium Acetate	Sodium acetate anhydrous 164 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0641-6262	00641-6262-01
Sodium Acetate	Sodium acetate 4 meq/100mL	Injection, Solution, ConcentrateIntravenous	Fresenius Kabi USA, LLC	63323-032	63323-0032-00

All 13 Sodium Acetate NDCs

Other NDCs under ANDA 216920

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

FDA NDC Directory listings under ANDA 216920
Product	Strength	Form · route	Labeler	Product NDC
Sodium Acetate	Sodium acetate anhydrous 164 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0641-6261
Sodium Acetate	Sodium acetate anhydrous 164 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0641-6262