NDC codes

FDA NDC Directory
Product NDC (as listed)67457-446Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67457-0446Add 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
67457-446-10674570446101 VIAL in 1 CARTON (67457-446-10) / 10 mL in 1 VIALMarketed from May 10, 2011

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)
Pamidronate Disodium
Generic name (nonproprietary)
pamidronate disodium
Active ingredients
Pamidronate disodium — 9 mg/mL
Dosage form
Injection
Route
Intravenous
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078520
Marketing start
Listing expires
Other FDA classes
Diphosphonates (Chemical structure)
Identifiers
Product ID 67457-446_e3a78042-50cb-49d9-a31e-51d8edddbf4cSPL ID e3a78042-50cb-49d9-a31e-51d8edddbf4cSPL set ID c2ca033e-fa5f-4141-b702-11f8b4303da1RxCUI 1737449, 1737453UNII 8742T8ZQZA
Pharmacologic class
Bisphosphonate

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.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N467457044610 followed by a unit qualifier and the quantity

Package 67457-0446-10. 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)

Pamidronate disodium is a bisphosphonate indicated for the treatment of: • moderate or severe hypercalcemia associated with malignancy, with or without bone metastases ( 1.1 ) • patients with moderate to severe Paget’s disease of bone ( 1.2 ) • osteolytic bone metastases of breast cancer or osteolytic lesions of multiple myeloma, in conjunction with standard antineoplastic therapy ( 1.3 ) Limitations of use Safety and efficacy of pamidronate disodium in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established. ( 1.4 ) 1.1 Hypercalcemia of Malignancy Pamidronate disodium is indicated for the treatment of moderate o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078520

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

FDA NDC Directory listings under ANDA 078520
ProductStrengthForm · routeLabelerProduct NDC
Pamidronate DisodiumPamidronate disodium 3 mg/mLInjectionIntravenousMylan Institutional LLC67457-430

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