NDC codes

FDA NDC Directory
Product NDC (as listed)52268-201Labeler and product segments. Claims need a package NDC.
Product NDC at billing width52268-0201Add 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 NDC11-digit (billing)PackageCopy
52268-201-0152268020101522680201012 BOTTLE, PLASTIC in 1 KIT (52268-201-01) / 12 TABLET in 1 BOTTLE, PLASTICMarketed from Nov 10, 2020

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)
Sutab
Generic name (nonproprietary)
sodium sulfate, magnesium sulfate, and potassium chloride
Active ingredients
Sodium sulfate — 17.75 g/1Magnesium sulfate anhydrous — 2.7 g/1Potassium chloride — 2.25 g/1
Dosage form
Tablet
Route
Oral
Labeler
Braintree Laboratories, Inc.NDC labeler code 52268
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 213135
Marketing start
Marketing end
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)Potassium Compounds (Chemical structure)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers
Product ID 52268-201_5d53f18c-bd7e-a644-e063-6294a90a1b8fSPL ID 5d53f18c-bd7e-a644-e063-6294a90a1b8f
Pharmacologic class
Calculi Dissolution Agent; Osmotic Laxative; Potassium Salt

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

N452268020101 followed by a unit qualifier and the quantity

Package 52268-0201-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 52268-201

What is NDC 52268-201?
52268-201 is the product NDC for Sutab, Sodium sulfate 17.75 g/1 + 2 more ingredients tablet, listed with the FDA by Braintree Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sutab (Sodium sulfate, magnesium sulfate, and potassium chloride).
What is the active ingredient?
Sodium sulfate, Magnesium sulfate anhydrous, Potassium chloride.
Who is the labeler?
Braintree Laboratories, Inc., NDC labeler code 52268. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sutab?
1 other product NDC are listed under this name. See all Sutab 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 Sutab NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Sutabsodium sulfate, magnesium sulfate, and potassium chlorideSodium sulfate 17.75 g/1 + 2 more ingredientsTabletOralAzurity Pharmaceuticals, Inc.24338-20124338-0201-01

Other NDCs under NDA 213135

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

FDA NDC Directory listings under NDA 213135
ProductStrengthForm · routeLabelerProduct NDC
Sutabsodium sulfate, magnesium sulfate, and potassium chlorideSodium sulfate 17.75 g/1 + 2 more ingredientsTabletOralAzurity Pharmaceuticals, Inc.24338-201

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