NDC 68462-647

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-647Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0647Add 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 NDC	11-digit (billing)	Package	Copy
68462-647-01	68462064701	100 TABLET in 1 BOTTLE (68462-647-01)Marketed from May 12, 2025

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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate
Generic name (nonproprietary): dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate
Active ingredients: Dextroamphetamine sulfate — 1.25 mg/1Amphetamine sulfate — 1.25 mg/1Amphetamine dl-aspartate — 1.25 mg/1Dextroamphetamine saccharate — 1.25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: GLENMARK PHARMACEUTICALS INC., USA
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210754
Marketing start: May 12, 2025
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 68462-647_a586519f-97a3-4a3a-951a-c3ecaab95334SPL ID a586519f-97a3-4a3a-951a-c3ecaab95334SPL set ID 4564e404-8d71-4585-ab78-55857f477143RxCUI 541363, 541878, 541892, 577957, 577961UNII G83415V073, 6DPV8NK46S, JJ768O327N, H527KAP6L5UPC 0368462653012, 0368462651018, 0368462649015, 0368462652015, 0368462647011
Pharmacologic class: Central Nervous System Stimulant

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

N468462064701 followed by a unit qualifier and the quantity

Package 68462-0647-01. 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 Jan 9, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD) A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV ® ) implies the presence of 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 two or more settings, e.g., school (or work) and at home. The symptoms must not be …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210754

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

FDA NDC Directory listings under ANDA 210754
Product	Strength	Form · route	Labeler	Product NDC
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate	Dextroamphetamine sulfate 7.5 mg/1 + 3 more ingredients	TabletOral	GLENMARK PHARMACEUTICALS INC., USA	68462-653
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate	Dextroamphetamine saccharate 2.5 mg/1 + 3 more ingredients	TabletOral	GLENMARK PHARMACEUTICALS INC., USA	68462-649
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate	Amphetamine sulfate 3.75 mg/1 + 3 more ingredients	TabletOral	GLENMARK PHARMACEUTICALS INC., USA	68462-651
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate	Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients	TabletOral	GLENMARK PHARMACEUTICALS INC., USA	68462-652

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate NDC 68462-647