NDC 11534-195

NDC codes

FDA NDC Directory

Product NDC (as listed)11534-195Labeler and product segments. Claims need a package NDC.

Product NDC at billing width11534-0195Add 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
11534-195-01	11534019501	100 TABLET in 1 BOTTLE (11534-195-01)Marketed from Jul 4, 2018
11534-195-03	11534019503	1000 TABLET in 1 BOTTLE (11534-195-03)Marketed from Jul 4, 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): Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate
Generic name (nonproprietary): dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
Active ingredients: Dextroamphetamine saccharate — 5 mg/1Amphetamine aspartate monohydrate — 5 mg/1Dextroamphetamine sulfate — 5 mg/1Amphetamine sulfate — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: SUNRISE PHARMACEUTICAL, INC.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209799
Marketing start: Jul 4, 2018
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)Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 11534-195_60dcfbf6-d07a-4010-ae77-8a9ae4529828SPL ID 60dcfbf6-d07a-4010-ae77-8a9ae4529828SPL set ID ac102599-3a5b-4154-899e-6ff262be7ff7RxCUI 541363, 541878, 541892, 577957, 577961, 687043, 1009145UNII O1ZPV620O4, G83415V073, 6DPV8NK46S, JJ768O327NUPC 0311534193039, 0311534192032, 0311534191035, 0311534196016, 0311534190038, 0311534196030, 0311534195033
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

N411534019501 followed by a unit qualifier and the quantity

Package 11534-0195-01. 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 Aug 4, 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 (Mixed Salts of a Single Amphetamine Product) 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 (o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209799

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

FDA NDC Directory listings under ANDA 209799
Product	Strength	Form · route	Labeler	Product NDC
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Dextroamphetamine saccharate 2.5 mg/1 + 3 more ingredients	TabletOral	SUNRISE PHARMACEUTICAL, INC.	11534-192
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Dextroamphetamine saccharate 1.875 mg/1 + 3 more ingredients	TabletOral	Bryant Ranch Prepack	72162-1235
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Dextroamphetamine saccharate 3.125 mg/1 + 3 more ingredients	TabletOral	Bryant Ranch Prepack	72162-1236
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Dextroamphetamine saccharate 1.25 mg/1 + 3 more ingredients	TabletOral	SUNRISE PHARMACEUTICAL, INC.	11534-190
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Dextroamphetamine saccharate 1.875 mg/1 + 3 more ingredients	TabletOral	SUNRISE PHARMACEUTICAL, INC.	11534-191
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Dextroamphetamine saccharate 3.125 mg/1 + 3 more ingredients	TabletOral	SUNRISE PHARMACEUTICAL, INC.	11534-193
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Dextroamphetamine saccharate 3.75 mg/1 + 3 more ingredients	TabletOral	SUNRISE PHARMACEUTICAL, INC.	11534-194
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Dextroamphetamine saccharate 7.5 mg/1 + 3 more ingredients	TabletOral	SUNRISE PHARMACEUTICAL, INC.	11534-196
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients	TabletOral	Bryant Ranch Prepack	72162-2251

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate NDC 11534-195