NDC codes

FDA NDC Directory
Product NDC (as listed)69543-410Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69543-0410Add 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
69543-410-1069543041010100 TABLET in 1 BOTTLE (69543-410-10)Marketed from Jul 1, 2018

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)
Phendimetrazine Tartrate
Generic name (nonproprietary)
phendimetrazine tartrate
Active ingredients
Phendimetrazine tartrate — 35 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Virtus Pharmaceuticals, LLCNDC labeler code 69543
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 085588
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
Identifiers
Product ID 69543-410_dc927d6a-f5b4-45e8-a732-c47831036d39SPL ID dc927d6a-f5b4-45e8-a732-c47831036d39SPL set ID cc9a0cd2-6fb9-47ab-8e39-146d2fa361c2RxCUI 979549UNII 6985IP0T80
Pharmacologic class
Sympathomimetic Amine Anorectic

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

N469543041010 followed by a unit qualifier and the quantity

Package 69543-0410-10. 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)

INDICATIONS AND USAGE Phendimetrazine tartrate tablets are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY ) should be measured against possible risk factors inherent in their use such as those described below.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69543-410

What is NDC 69543-410?
69543-410 is the product NDC for Phendimetrazine Tartrate, Phendimetrazine tartrate 35 mg/1 tablet, listed with the FDA by Virtus Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Phendimetrazine Tartrate.
What is the active ingredient?
Phendimetrazine tartrate.
Who is the labeler?
Virtus Pharmaceuticals, LLC, NDC labeler code 69543. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Phendimetrazine Tartrate?
19 other product NDCs are listed under this name. See all Phendimetrazine Tartrate 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 Phendimetrazine Tartrate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Phendimetrazine TartratePhendimetrazine tartrate 105 mg/1Capsule, Extended releaseOralAcertis Pharmaceuticals, LLC72989-40972989-0409-30
Phendimetrazine TartratePhendimetrazine tartrate 35 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-723668788-7236-0168788-7236-0268788-7236-03+1 more
Phendimetrazine TartratePhendimetrazine tartrate 35 mg/1TabletOralBryant Ranch Prepack63629-248963629-2489-01
Phendimetrazine TartratePhendimetrazine tartrate 35 mg/1TabletOralBryant Ranch Prepack71335-184071335-1840-0071335-1840-0171335-1840-02+7 more
Phendimetrazine TartratePhendimetrazine tartrate 35 mg/1TabletOralElite Laboratories, Inc64850-44064850-0440-0164850-0440-10
Phendimetrazine TartratePhendimetrazine tartrate 35 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-350968071-3509-0168071-3509-0668071-3509-08+1 more
Phendimetrazine TartratePhendimetrazine tartrate 35 mg/1TabletOralBryant Ranch Prepack72162-204472162-2044-0072162-2044-0172162-2044-03+1 more
Phendimetrazine TartratePhendimetrazine tartrate 35 mg/1TabletOralKVK-TECH, INC10702-04510702-0045-0110702-0045-0310702-0045-10
Phendimetrazine TartratePhendimetrazine tartrate 35 mg/1TabletOralKVK-TECH, INC10702-07710702-0077-0110702-0077-0310702-0077-10
Phendimetrazine TartratePhendimetrazine tartrate 35 mg/1TabletOralKVK-TECH, INC10702-07810702-0078-0110702-0078-0310702-0078-10

All 20 Phendimetrazine Tartrate NDCs

Other NDCs under ANDA 085588

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

FDA NDC Directory listings under ANDA 085588
ProductStrengthForm · routeLabelerProduct NDC
Phendimetrazine TartratePhendimetrazine tartrate 35 mg/1TabletOralBryant Ranch Prepack63629-2489
Phendimetrazine TartratePhendimetrazine tartrate 35 mg/1TabletOralBryant Ranch Prepack71335-1840

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