Prescription drug · ANDA

Sodium Polystyrene Sulfonate NDC 11534-166

Sodium polystyrene sulfonate 4.1 meq/g · Powder, For suspension · Oral, Rectal · SUNRISE PHARMACEUTICAL, INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)11534-166Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11534-0166Add 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
11534-166-15115340166151153401661515 g in 1 BOTTLE (11534-166-15)Marketed from Jan 24, 2017
11534-166-16115340166161153401661615 g in 1 BOTTLE (11534-166-16)Marketed from Jan 24, 2017
11534-166-441153401664411534016644454 g in 1 JAR (11534-166-44)Marketed from Jan 24, 2017

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 Polystyrene Sulfonate
Generic name (nonproprietary)
sodium polystyrene sulfonate
Active ingredients
Sodium polystyrene sulfonate — 4.1 meq/g
Dosage form
Powder, For suspension
Route
Oral, Rectal
Labeler
SUNRISE PHARMACEUTICAL, INC.NDC labeler code 11534
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204071
Marketing start
Listing expires
Identifiers
Product ID 11534-166_c5432731-23bc-44cf-bfcc-e59d16437db2SPL ID c5432731-23bc-44cf-bfcc-e59d16437db2SPL set ID c73b9661-2378-4336-8be0-098e7c1ae522RxCUI 2101899UNII 1699G8679ZUPC 0311534166446

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

N411534016615 followed by a unit qualifier and the quantity

Package 11534-0166-15. 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 .

Indications (excerpt from the label)

Sodium polystyrene sulfonate for suspension is indicated for the treatment of hyperkalemia. Limitation of Use : Sodium polystyrene sulfonate for suspension should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see Clinical Pharmacology (12.2) ] Sodium polystyrene sulfonate for suspension is a potassium binder indicated for the treatment of hyperkalemia ( 1 ). Limitation of Use : Sodium polystyrene sulfonate for suspension should not be used an emergency treatment for life threatening hyperkalemia because of its delayed onset of action ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 11534-166

What is NDC 11534-166?
11534-166 is the product NDC for Sodium Polystyrene Sulfonate, Sodium polystyrene sulfonate 4.1 meq/g powder, for suspension, listed with the FDA by SUNRISE PHARMACEUTICAL, INC.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sodium Polystyrene Sulfonate.
What is the active ingredient?
Sodium polystyrene sulfonate.
Who is the labeler?
SUNRISE PHARMACEUTICAL, INC., NDC labeler code 11534. 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 Polystyrene Sulfonate?
14 other product NDCs are listed under this name. See all Sodium Polystyrene Sulfonate 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 Polystyrene Sulfonate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Sodium Polystyrene SulfonateSodium polystyrene sulfonate 15 g/60mLSuspensionOral, RectalBurel Pharmaceuticals, LLC35573-10835573-0108-1435573-0108-57
Sodium Polystyrene SulfonateSodium polystyrene sulfonate 4.1 meq/gPowder, For suspensionOral, RectalBryant Ranch Prepack63629-239063629-2390-01
Sodium Polystyrene SulfonateSodium polystyrene sulfonate 4.1 meq/gPowder, For suspensionOral, RectalBryant Ranch Prepack63629-884963629-8849-01
Sodium Polystyrene SulfonateSodium polystyrene sulfonate 4.1 meq/gPowder, For suspensionOral, RectalBryant Ranch Prepack63629-885063629-8850-01
Sodium Polystyrene SulfonateSodium polystyrene sulfonate 4.1 meq/gPowder, For suspensionOral, RectalBryant Ranch Prepack71335-285571335-2855-01
Sodium Polystyrene SulfonateSodium polystyrene sulfonate 4.1 meq/gPowder, For suspensionOral, RectalBryant Ranch Prepack72162-123072162-1230-0272162-1230-07
Sodium Polystyrene SulfonateSodium polystyrene sulfonate 4.1 meq/gPowder, For suspensionOralPuraCap Laboratories, LLC24658-76024658-0760-16
Sodium Polystyrene SulfonateSodium polystyrene sulfonate 4.1 meq/gPowder, For suspensionOral, RectalChartwell RX, LLC62135-34062135-0340-1162135-0340-5362135-0340-62
Sodium Polystyrene SulfonateSodium polystyrene sulfonate 4.1 meq/gPowder, For suspensionOralATLANTIC BIOLOGICALS CORP.17856-002417856-0024-0117856-0024-02
Sodium Polystyrene SulfonateSodium polystyrene sulfonate 4.1 meq/gPowder, For suspensionOralEpic Pharma, LLC42806-01342806-0013-9442806-0013-96

All 15 Sodium Polystyrene Sulfonate NDCs

Other NDCs under ANDA 204071

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

FDA NDC Directory listings under ANDA 204071
ProductStrengthForm · routeLabelerProduct NDC
Sodium Polystyrene SulfonateSodium polystyrene sulfonate 4.1 meq/gPowder, For suspensionOral, RectalBryant Ranch Prepack63629-2390
Sodium Polystyrene SulfonateSodium polystyrene sulfonate 4.1 meq/gPowder, For suspensionOral, RectalBryant Ranch Prepack63629-8849
Sodium Polystyrene SulfonateSodium polystyrene sulfonate 4.1 meq/gPowder, For suspensionOral, RectalBryant Ranch Prepack63629-8850
Sodium Polystyrene SulfonateSodium polystyrene sulfonate 4.1 meq/gPowder, For suspensionOral, RectalBryant Ranch Prepack71335-2855
Sodium Polystyrene SulfonateSodium polystyrene sulfonate 4.1 meq/gPowder, For suspensionOral, RectalBryant Ranch Prepack72162-1230

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