Adderall NDC 57844-105

NDC codes

FDA NDC Directory

Product NDC (as listed)57844-105Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57844-0105Add 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
57844-105-01	57844010501	100 TABLET in 1 BOTTLE (57844-105-01)Marketed from Nov 13, 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): Adderall
Generic name (nonproprietary): dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Active ingredients: Dextroamphetamine saccharate — 1.25 mg/1Amphetamine aspartate monohydrate — 1.25 mg/1Dextroamphetamine sulfate — 1.25 mg/1Amphetamine sulfate — 1.25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Teva Pharmaceuticals USA, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040422
Marketing start: Nov 13, 2014
Listing expires: Dec 31, 2026
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 57844-105_79af1dc6-c7cf-41b1-a750-e9b47c2187ffSPL ID 79af1dc6-c7cf-41b1-a750-e9b47c2187ffSPL set ID f22635fe-821d-4cde-aa12-419f8b53db81RxCUI 541363, 541365, 541878, 541879, 541892, 541894, 577957, 577960, 577961, 577962, 687043, 687045, 1009145, 1009147UNII JJ768O327N, O1ZPV620O4, 6DPV8NK46S, G83415V073
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

N457844010501 followed by a unit qualifier and the quantity

Package 57844-0105-01. 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 May 29, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Adderall ® (Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets (Mixed salts of a single entity amphetamine product)) is 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 settin…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040422

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

FDA NDC Directory listings under ANDA 040422
Product	Strength	Form · route	Labeler	Product NDC
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine saccharate 3.75 mg/1 + 3 more ingredients	TabletOral	Teva Pharmaceuticals USA, Inc.	0555-0777
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine saccharate 1.25 mg/1 + 3 more ingredients	TabletOral	Teva Pharmaceuticals USA, Inc.	0555-0971
Adderalldextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate 3.75 mg/1 + 3 more ingredients	TabletOral	Teva Pharmaceuticals USA, Inc.	57844-115
Adderalldextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate 2.5 mg/1 + 3 more ingredients	TabletOral	Teva Pharmaceuticals USA, Inc.	57844-110
Adderalldextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate 3.125 mg/1 + 3 more ingredients	TabletOral	Teva Pharmaceuticals USA, Inc.	57844-112
Adderalldextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate 1.875 mg/1 + 3 more ingredients	TabletOral	Teva Pharmaceuticals USA, Inc.	57844-117
Adderalldextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients	TabletOral	Teva Pharmaceuticals USA, Inc.	57844-120
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine saccharate 2.5 mg/1 + 3 more ingredients	TabletOral	Teva Pharmaceuticals USA, Inc.	0555-0972
Adderalldextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate	Dextroamphetamine saccharate 7.5 mg/1 + 3 more ingredients	TabletOral	Teva Pharmaceuticals USA, Inc.	57844-130
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients	TabletOral	Teva Pharmaceuticals USA, Inc.	0555-0973
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine saccharate 7.5 mg/1 + 3 more ingredients	TabletOral	Teva Pharmaceuticals USA, Inc.	0555-0974
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine saccharate 1.875 mg/1 + 3 more ingredients	TabletOral	Teva Pharmaceuticals USA, Inc.	0555-0775
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine saccharate 3.125 mg/1 + 3 more ingredients	TabletOral	Teva Pharmaceuticals USA, Inc.	0555-0776