NDC codes

FDA NDC Directory
Product NDC (as listed)45963-305Labeler and product segments. Claims need a package NDC.
Product NDC at billing width45963-0305Add 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
45963-305-094596303050990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-305-09)Marketed from Jun 19, 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)
dextroamphetamine sulfate
Generic name (nonproprietary)
dextroamphetamine sulfate
Active ingredients
Dextroamphetamine sulfate — 15 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203901
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Central Nervous System Stimulation (Physiologic effect)
Identifiers
Product ID 45963-305_efcdbc4d-7174-4356-9aa2-d557735e2048SPL ID efcdbc4d-7174-4356-9aa2-d557735e2048SPL set ID 9e92ccc3-d81c-461d-a19f-7e9b582be357RxCUI 884520, 884532, 884535UNII JJ768O327NUPC 0345963305091, 0345963304094, 0345963303097

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

N445963030509 followed by a unit qualifier and the quantity

Package 45963-0305-09. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Dextroamphetamine sulfate extended-release capsules are indicated in: Narcolepsy Attention Deficit Disorder with Hyperactivity As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of the hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., sc…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203901

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

FDA NDC Directory listings under ANDA 203901
ProductStrengthForm · routeLabelerProduct NDC
dextroamphetamine sulfateDextroamphetamine sulfate 10 mg/1Capsule, Extended releaseOralActavis Pharma, Inc.45963-304
dextroamphetamine sulfateDextroamphetamine sulfate 5 mg/1Capsule, Extended releaseOralActavis Pharma, Inc.45963-303

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