NDC codes

FDA NDC Directory
Product NDC (as listed)69097-862Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69097-0862Add 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
69097-862-036909708620360 CAPSULE in 1 BOTTLE (69097-862-03)Marketed from Jul 26, 2016
69097-862-8369097086283200 CAPSULE in 1 BOTTLE (69097-862-83)Marketed from Jul 26, 2016

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)
Calcium Acetate
Generic name (nonproprietary)
calcium acetate
Active ingredients
Calcium acetate — 667 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203135
Marketing start
Listing expires
Other FDA classes
Calcium (Chemical structure)Divalent (Chemical structure)Increased Coagulation Factor Activity (Physiologic effect)
Identifiers
Product ID 69097-862_7749772b-1a26-4b2e-b97d-3ee29611d035SPL ID 7749772b-1a26-4b2e-b97d-3ee29611d035SPL set ID 000c044a-12ef-4484-942e-99552b777d58RxCUI 359296UNII Y882YXF34X
Pharmacologic class
Blood Coagulation Factor

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

N469097086203 followed by a unit qualifier and the quantity

Package 69097-0862-03. 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)

Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203135

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

FDA NDC Directory listings under ANDA 203135
ProductStrengthForm · routeLabelerProduct NDC
Calcium AcetateCalcium acetate 667 mg/1CapsuleOralAmerican Health Packaging60687-589
Calcium AcetateCalcium acetate 667 mg/1CapsuleOralEXELAN PHARMACEUTICALS, INC.76282-377

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