NDC codes

FDA NDC Directory
Product NDC (as listed)76282-377Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76282-0377Add 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
76282-377-027628203770276282037702200 CAPSULE in 1 BOTTLE (76282-377-02)Marketed from Apr 14, 2014
76282-377-60762820377607628203776060 CAPSULE in 1 BOTTLE (76282-377-60)Marketed from Apr 14, 2014

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
Labeler
EXELAN PHARMACEUTICALS, INC.NDC labeler code 76282
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 76282-377_b22d0aaf-0636-492b-981f-6c220640c1cdSPL ID b22d0aaf-0636-492b-981f-6c220640c1cdSPL set ID a5725f95-621e-425b-946d-434b3fec24ebRxCUI 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

N476282037702 followed by a unit qualifier and the quantity

Package 76282-0377-02. 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)

About NDC 76282-377

What is NDC 76282-377?
76282-377 is the product NDC for Calcium Acetate, Calcium acetate 667 mg/1 capsule, listed with the FDA by EXELAN PHARMACEUTICALS, INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Calcium Acetate.
What is the active ingredient?
Calcium acetate.
Who is the labeler?
EXELAN PHARMACEUTICALS, INC., NDC labeler code 76282. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Calcium Acetate?
21 other product NDCs are listed under this name. See all Calcium Acetate 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 Calcium Acetate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Calcium AcetateCalcium acetate 667 mg/1CapsuleOralAmerican Health Packaging60687-58960687-0589-65
Calcium AcetateCalcium acetate 667 mg/1CapsuleOralAvPAK50268-20350268-0203-15
Calcium AcetateCalcium acetate 667 mg/1CapsuleOralWestminster Pharmaceuticals, LLC69367-41169367-0411-02
Calcium AcetateCalcium acetate 667 mg/1CapsuleOralProficient Rx LP82804-96882804-0968-0082804-0968-2082804-0968-30+6 more
calcium acetateCalcium acetate 667 mg/1CapsuleOralAvKARE73190-03173190-0031-20
calcium acetateCalcium acetate 667 mg/1CapsuleOralREMEDYREPACK INC.70518-429970518-4299-00
Calcium AcetateCalcium acetate 667 mg/1CapsuleOralNCS HealthCare of KY, LLC dba Vangard Labs0615-863200615-8632-39
Calcium AcetateCalcium acetate 667 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.72789-42272789-0422-97
Calcium AcetateCalcium acetate 667 mg/1CapsuleOralNivagen Pharmaceuticals, Inc.75834-32375834-0323-02
Calcium AcetateCalcium acetate 667 mg/1CapsuleOralSQUARE PHARMACEUTICALS LIMITED76483-08676483-0086-00

All 22 Calcium Acetate NDCs

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/1CapsuleOralCipla USA Inc.,69097-862

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