NDC 70010-031

NDC codes

FDA NDC Directory

Product NDC (as listed)70010-031Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70010-0031Add 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
70010-031-01	70010003101	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-031-01)Marketed from Feb 20, 2023

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 monohydrate, dextroamphetamine sulfate and amphetamine sulfate
Generic name (nonproprietary): dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate
Active ingredients: Dextroamphetamine saccharate — 3.75 mg/1Amphetamine aspartate monohydrate — 3.75 mg/1Dextroamphetamine sulfate — 3.75 mg/1Amphetamine sulfate — 3.75 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Granules Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217027
Marketing start: Feb 20, 2023
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 70010-031_51ac9d68-0275-7d80-e063-6294a90a5ccbSPL ID 51ac9d68-0275-7d80-e063-6294a90a5ccbSPL set ID 8c672e06-0778-4a7d-b398-5bcbf2a73f12RxCUI 861221, 861223, 861225, 861227, 861232, 861237UNII O1ZPV620O4, G83415V073, 6DPV8NK46S, JJ768O327NUPC 0370010029019, 0370010030015, 0370010032019, 0370010034013, 0370010031012, 0370010033016
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

N470010003101 followed by a unit qualifier and the quantity

Package 70010-0031-01. 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 13, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

N/A Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules, a CNS stimulant, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. ( 1 ) Limitations of Use The use of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules are not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 217027

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

FDA NDC Directory listings under ANDA 217027
Product	Strength	Form · route	Labeler	Product NDC
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate	Dextroamphetamine saccharate 2.5 mg/1 + 3 more ingredients	Capsule, Extended releaseOral	Granules Pharmaceuticals Inc.	70010-030
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate	Dextroamphetamine saccharate 1.25 mg/1 + 3 more ingredients	Capsule, Extended releaseOral	Granules Pharmaceuticals Inc.	70010-029
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate	Dextroamphetamine saccharate 5 mg/1 + 3 more ingredients	Capsule, Extended releaseOral	Granules Pharmaceuticals Inc.	70010-032
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate	Dextroamphetamine saccharate 6.25 mg/1 + 3 more ingredients	Capsule, Extended releaseOral	Granules Pharmaceuticals Inc.	70010-033
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate	Dextroamphetamine saccharate 7.5 mg/1 + 3 more ingredients	Capsule, Extended releaseOral	Granules Pharmaceuticals Inc.	70010-034

dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate NDC 70010-031