What is NDC 45963-303?

45963-303 is the product NDC for dextroamphetamine sulfate, Dextroamphetamine sulfate 5 mg/1 capsule, extended release, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Actavis Pharma, Inc., NDC labeler code 45963. 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 sulfate?

38 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

dextroamphetamine sulfate NDC 45963-303

NDC codes

FDA NDC Directory

Product NDC (as listed)45963-303Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45963-0303Add 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
45963-303-09	4596303030945963030309	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-303-09)Marketed from Jun 19, 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): dextroamphetamine sulfate
Generic name (nonproprietary): dextroamphetamine sulfate
Active ingredients: Dextroamphetamine sulfate — 5 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Actavis Pharma, Inc.NDC labeler code 45963
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203901
Marketing start: Jun 19, 2014
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)
Identifiers: Product ID 45963-303_fd3ab328-e56c-4180-a0df-d6aa0375cf58SPL ID fd3ab328-e56c-4180-a0df-d6aa0375cf58
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

N445963030309 followed by a unit qualifier and the quantity

Package 45963-0303-09. 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 45963-303

What is NDC 45963-303?: 45963-303 is the product NDC for dextroamphetamine sulfate, Dextroamphetamine sulfate 5 mg/1 capsule, extended release, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: dextroamphetamine sulfate.
What is the active ingredient?: Dextroamphetamine sulfate.
Who is the labeler?: Actavis Pharma, Inc., NDC labeler code 45963. 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 sulfate?: 38 other product NDCs are listed under this name. See all dextroamphetamine sulfate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other dextroamphetamine sulfate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Dextroamphetamine Sulfate	Dextroamphetamine sulfate 5 mg/1	TabletOral	Cranbury Pharmaceuticals, LLC	27808-089	27808-0089-01
Dextroamphetamine Sulfate	Dextroamphetamine sulfate 10 mg/1	TabletOral	Cranbury Pharmaceuticals, LLC	27808-090	27808-0090-01
Dextroamphetamine Sulfate	Dextroamphetamine sulfate 2.5 mg/1	TabletOral	Winder Laboratories LLC	75826-120	75826-0120-1075826-0120-30
Dextroamphetamine Sulfate	Dextroamphetamine sulfate 5 mg/1	TabletOral	Winder Laboratories LLC	75826-121	75826-0121-1075826-0121-30
Dextroamphetamine Sulfate	Dextroamphetamine sulfate 7.5 mg/1	TabletOral	Winder Laboratories LLC	75826-122	75826-0122-1075826-0122-30
Dextroamphetamine Sulfate	Dextroamphetamine sulfate 10 mg/1	TabletOral	Winder Laboratories LLC	75826-123	75826-0123-1075826-0123-30
Dextroamphetamine Sulfate	Dextroamphetamine sulfate 15 mg/1	TabletOral	Winder Laboratories LLC	75826-124	75826-0124-1075826-0124-30
Dextroamphetamine Sulfate	Dextroamphetamine sulfate 20 mg/1	TabletOral	Winder Laboratories LLC	75826-125	75826-0125-1075826-0125-30
Dextroamphetamine Sulfate	Dextroamphetamine sulfate 30 mg/1	TabletOral	Winder Laboratories LLC	75826-126	75826-0126-1075826-0126-30
Dextroamphetamine Sulfate	Dextroamphetamine sulfate 15 mg/1	TabletOral	Wilshire Pharmaceuticals, Inc.	52536-515	52536-0515-03

All 39 dextroamphetamine sulfate NDCs

Other NDCs under ANDA 203901

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

FDA NDC Directory listings under ANDA 203901
Product	Strength	Form · route	Labeler	Product NDC
dextroamphetamine sulfate	Dextroamphetamine sulfate 10 mg/1	Capsule, Extended releaseOral	Actavis Pharma, Inc.	45963-304
dextroamphetamine sulfate	Dextroamphetamine sulfate 15 mg/1	Capsule, Extended releaseOral	Actavis Pharma, Inc.	45963-305