What is NDC 83634-501?

83634-501 is the product NDC for Magnesium Sulfate in Water, Magnesium sulfate heptahydrate 80 mg/mL injection, solution, listed with the FDA by Avenacy, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Magnesium sulfate heptahydrate.

Avenacy, LLC, NDC labeler code 83634. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Magnesium Sulfate in Water?

17 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Magnesium Sulfate in Water NDC 83634-501

NDC codes

FDA NDC Directory

Product NDC (as listed)83634-501Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83634-0501Add 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
83634-501-81	8363405018183634050181	24 POUCH in 1 CARTON (83634-501-81) / 1 BAG in 1 POUCH (83634-501-41) / 50 mL in 1 BAGMarketed from Apr 22, 2024
83634-501-82	8363405018283634050182	30 POUCH in 1 CARTON (83634-501-82) / 1 BAG in 1 POUCH (83634-501-41) / 50 mL in 1 BAGMarketed from Sep 15, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Magnesium Sulfate in Water
Generic name (nonproprietary): magnesium sulfate in water
Active ingredients: Magnesium sulfate heptahydrate — 80 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Avenacy, LLCNDC labeler code 83634
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209642
Marketing start: Apr 22, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Small Intestine Fluid/Electrolyte Absorption (Physiologic effect)Magnesium Ion Exchange Activity (Mechanism)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers: Product ID 83634-501_74a0488c-befd-4f6b-af07-d06834e8202aSPL ID 74a0488c-befd-4f6b-af07-d06834e8202aSPL set ID f50f4e06-288c-4b5e-9260-f3fe0a210c0cRxCUI 829734, 1658259, 1658262UNII SK47B8698T
Pharmacologic class: Calculi Dissolution Agent; 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

N483634050181 followed by a unit qualifier and the quantity

Package 83634-0501-81. 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 Sep 15, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83634-501

What is NDC 83634-501?: 83634-501 is the product NDC for Magnesium Sulfate in Water, Magnesium sulfate heptahydrate 80 mg/mL injection, solution, listed with the FDA by Avenacy, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Magnesium Sulfate in Water.
What is the active ingredient?: Magnesium sulfate heptahydrate.
Who is the labeler?: Avenacy, LLC, NDC labeler code 83634. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Magnesium Sulfate in Water?: 17 other product NDCs are listed under this name. See all Magnesium Sulfate in Water 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 Magnesium Sulfate in Water NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Magnesium Sulfate in Water	Magnesium sulfate heptahydrate 40 mg/mL	Injection, SolutionIntravenous	Avenacy, LLC	83634-500	83634-0500-8183634-0500-8283634-0500-83
Magnesium Sulfate in Water	Magnesium sulfate heptahydrate 40 g/1000mL	Injection, SolutionIntravenous	Hospira, Inc.	0409-3164	00409-3164-12
Magnesium Sulfate in Water	Magnesium sulfate heptahydrate 40 mg/mL	Injection, SolutionIntravenous	Athenex Pharmaceutical Division, LLC.	70860-501	70860-0501-8170860-0501-82
Magnesium Sulfate in Water	Magnesium sulfate heptahydrate 80 mg/mL	Injection, SolutionIntravenous	Athenex Pharmaceutical Division, LLC.	70860-502	70860-0502-81
Magnesium Sulfate in Water	Magnesium sulfate heptahydrate 4 g/100mL	Injection, SolutionIntravenous	Hospira, Inc.	0409-4121	00409-4121-24
Magnesium Sulfate in Water	Magnesium sulfate heptahydrate 2 g/50mL	Injection, SolutionIntravenous	Hospira, Inc.	0409-5239	00409-5239-24
Magnesium Sulfate in Water	Magnesium sulfate heptahydrate 20 g/500mL	Injection, SolutionIntravenous	Hospira, Inc.	0409-2050	00409-2050-20
Magnesium Sulfate in Watermagnesium sulfate heptahydrate	Magnesium sulfate heptahydrate 2 g/50mL	Injection, SolutionIntravenous	B. Braun Medical Inc.	0264-4204	00264-4204-52
Magnesium Sulfate in Watermagnesium sulfate heptahydrate	Magnesium sulfate heptahydrate 4 g/50mL	Injection, SolutionIntravenous	B. Braun Medical Inc.	0264-4205	00264-4205-52
Magnesium Sulfate in Watermagnesium sulfate heptahydrate	Magnesium sulfate heptahydrate 4 g/100mL	Injection, SolutionIntravenous	B. Braun Medical Inc.	0264-4206	00264-4206-54

All 18 Magnesium Sulfate in Water NDCs

Other NDCs under ANDA 209642

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

FDA NDC Directory listings under ANDA 209642
Product	Strength	Form · route	Labeler	Product NDC
Magnesium Sulfate in Water	Magnesium sulfate heptahydrate 40 mg/mL	Injection, SolutionIntravenous	Athenex Pharmaceutical Division, LLC.	70860-501
Magnesium Sulfate in Water	Magnesium sulfate heptahydrate 80 mg/mL	Injection, SolutionIntravenous	Athenex Pharmaceutical Division, LLC.	70860-502
Magnesium Sulfate in Water	Magnesium sulfate heptahydrate 40 mg/mL	Injection, SolutionIntravenous	Avenacy, LLC	83634-500