Unfinished product

This listing is a drug for further processing, not a finished drug product dispensed or administered to patients. It is not normally billed.

NDC codes

FDA NDC Directory
Product NDC (as listed)0480-3296Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00480-3296Add 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
0480-3296-99004803296990048032969914719 CAPSULE, EXTENDED RELEASE in 1 CONTAINER (0480-3296-99)Marketed from 06-NOV-24

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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

Generic name (nonproprietary)
phentermine and topiramate
Active ingredients
Phentermine hydrochloride — 7.5 mg/1Topiramate — 46 mg/1
Dosage form
Capsule, Extended release
Labeler
Teva Pharmaceuticals, Inc.NDC labeler code 0480
Product type
Drug for further processing
Marketing category
Drug for further processing
Marketing start
Listing expires
DEA schedule
CIV
Identifiers
Product ID 0480-3296_1164ca5c-4e20-4373-a381-f8f66dabd035SPL ID 1164ca5c-4e20-4373-a381-f8f66dabd035

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

N400480329699 followed by a unit qualifier and the quantity

Package 00480-3296-99. 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 0480-3296

What is NDC 0480-3296?
0480-3296 is the product NDC for Phentermine and topiramate, Phentermine hydrochloride 7.5 mg/1; Topiramate 46 mg/1 capsule, extended release, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Phentermine and topiramate.
What is the active ingredient?
Phentermine hydrochloride, Topiramate.
Who is the labeler?
Teva Pharmaceuticals, Inc., NDC labeler code 0480. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Phentermine and topiramate?
5 other product NDCs are listed under this name. See all Phentermine and topiramate 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 Phentermine and topiramate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
phentermine and topiramatePhentermine hydrochloride 3.75 mg/1; Topiramate 23 mg/1Capsule, Extended releaseOralPrasco Laboratories66993-78066993-0780-30
phentermine and topiramatePhentermine hydrochloride 7.5 mg/1; Topiramate 46 mg/1Capsule, Extended releaseOralPrasco Laboratories66993-78166993-0781-30
phentermine and topiramatePhentermine hydrochloride 11.25 mg/1; Topiramate 69 mg/1Capsule, Extended releaseOralPrasco Laboratories66993-78266993-0782-30
phentermine and topiramatePhentermine hydrochloride 15 mg/1; Topiramate 92 mg/1Capsule, Extended releaseOralPrasco Laboratories66993-78366993-0783-30
Phentermine and topiramatePhentermine hydrochloride 11.25 mg/1; Topiramate 69 mg/1Capsule, Extended releaseOralTeva Pharmaceuticals, Inc.0480-229900480-2299-56
Phentermine and topiramatePhentermine hydrochloride 15 mg/1; Topiramate 92 mg/1Capsule, Extended releaseOralTeva Pharmaceuticals, Inc.0480-329500480-3295-56

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