NDC 43386-700

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-700Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0700Add 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
43386-700-83	43386070083	2 BOTTLE in 1 CARTON (43386-700-83) / 177 mL in 1 BOTTLEMarketed from Dec 30, 2022

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): Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate
Generic name (nonproprietary): sodium sulfate, potassium sulfate, magnesium sulfate
Active ingredients: Sodium sulfate — 17.5 g/177mLPotassium sulfate — 3.13 g/177mLMagnesium sulfate anhydrous — 1.6 g/177mL
Dosage form: Solution
Route: Oral
Labeler: Lupin Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202511
Marketing start: Dec 30, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Increased Large Intestinal Motility (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (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)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers: Product ID 43386-700_9fffaef0-0578-452d-a365-166b183d8e00SPL ID 9fffaef0-0578-452d-a365-166b183d8e00SPL set ID d4883657-d27d-4056-a567-5fb12d5e05d1RxCUI 1001689, 1120068UNII 0YPR65R21J, 1K573LC5TV, ML30MJ2U7I
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N443386070083 followed by a unit qualifier and the quantity

Package 43386-0700-83. 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 Dec 15, 2025.

Indications (excerpt from the label)

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202511

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

FDA NDC Directory listings under ANDA 202511
Product	Strength	Form · route	Labeler	Product NDC
Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate	Sodium sulfate 17.5 g/177mL + 2 more ingredients	SolutionOral	Novel Laboratories, Inc.	40032-700

Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate NDC 43386-700