What is NDC 57664-950?

57664-950 is the product NDC for Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate, Dextroamphetamine saccharate 3.125 mg/1 + 3 more ingredients capsule, extended release, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate.

What is the active ingredient?

Dextroamphetamine saccharate, Amphetamine aspartate monohydrate, Dextroamphetamine sulfate, Amphetamine sulfate.

Sun Pharmaceutical Industries, Inc., NDC labeler code 57664. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

NDC 57664-950

NDC codes

FDA NDC Directory

Product NDC (as listed)57664-950Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57664-0950Add 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
57664-950-88	57664095088	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (57664-950-88)Marketed from Feb 1, 2024

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, amphetamine sulfate
Generic name (nonproprietary): dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate
Active ingredients: Dextroamphetamine saccharate — 3.125 mg/1Amphetamine aspartate monohydrate — 3.125 mg/1Dextroamphetamine sulfate — 3.125 mg/1Amphetamine sulfate — 3.125 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 57664
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215997
Marketing start: Feb 1, 2024
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 57664-950_5a4aa049-9d52-1bbf-e063-6294a90a5770SPL ID 5a4aa049-9d52-1bbf-e063-6294a90a5770
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

N457664095088 followed by a unit qualifier and the quantity

Package 57664-0950-88. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 57664-950

What is NDC 57664-950?: 57664-950 is the product NDC for Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate, Dextroamphetamine saccharate 3.125 mg/1 + 3 more ingredients capsule, extended release, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate.
What is the active ingredient?: Dextroamphetamine saccharate, Amphetamine aspartate monohydrate, Dextroamphetamine sulfate, Amphetamine sulfate.
Who is the labeler?: Sun Pharmaceutical Industries, Inc., NDC labeler code 57664. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 215997

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

FDA NDC Directory listings under ANDA 215997
Product	Strength	Form · route	Labeler	Product NDC
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate	Dextroamphetamine saccharate 6.25 mg/1 + 3 more ingredients	Capsule, Extended releaseOral	Sun Pharmaceutical Industries, Inc.	57664-951
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate	Dextroamphetamine saccharate 9.375 mg/1 + 3 more ingredients	Capsule, Extended releaseOral	Sun Pharmaceutical Industries, Inc.	57664-952
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate	Dextroamphetamine saccharate 12.5 mg/1 + 3 more ingredients	Capsule, Extended releaseOral	Sun Pharmaceutical Industries, Inc.	57664-953

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate NDC 57664-950