NDC codes

FDA NDC Directory
Product NDC (as listed)52268-550Labeler and product segments. Claims need a package NDC.
Product NDC at billing width52268-0550Add 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
52268-550-0152268055001522680550011 KIT in 1 KIT (52268-550-01)Marketed from Jun 15, 2023

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)
Suflave
Generic name (nonproprietary)
polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution
Dosage form
Kit
Labeler
Braintree Laboratories, Inc.NDC labeler code 52268
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 215344
Marketing start
Marketing end
Identifiers
Product ID 52268-550_5d53fc0a-8427-ff9e-e063-6394a90a0e84SPL ID 5d53fc0a-8427-ff9e-e063-6394a90a0e84

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.

NDC on a medical claim

N452268055001 followed by a unit qualifier and the quantity

Package 52268-0550-01. 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 52268-550

What is NDC 52268-550?
52268-550 is the product NDC for Suflave kit, 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?
Suflave (Polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution).
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 Suflave?
1 other product NDC are listed under this name. See all Suflave 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 Suflave NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Suflavepolyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution—KitAzurity Pharmaceuticals, Inc.24338-55024338-0550-01

Other NDCs under NDA 215344

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

FDA NDC Directory listings under NDA 215344
ProductStrengthForm · routeLabelerProduct NDC
Suflavepolyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution—KitAzurity Pharmaceuticals, Inc.24338-550

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