NDC codes

FDA NDC Directory
Product NDC (as listed)27808-085Labeler and product segments. Claims need a package NDC.
Product NDC at billing width27808-0085Add 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 NDC11-digit (billing)PackageCopy
27808-085-012780800850127808008501473 mL in 1 BOTTLE, PLASTIC (27808-085-01)Marketed from May 31, 2013

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
Generic name (nonproprietary)
dextroamphetamine
Active ingredients
Dextroamphetamine sulfate — 5 mg/5mL
Dosage form
Solution
Route
Oral
Labeler
Cranbury Pharmaceuticals, LLCNDC labeler code 27808
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203644
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Central Nervous System Stimulation (Physiologic effect)
Identifiers
Product ID 27808-085_442f3920-82b4-41ab-b485-24954a2ebddbSPL ID 442f3920-82b4-41ab-b485-24954a2ebddbSPL set ID 7658071e-ee2c-4d23-94ce-1906959ec036RxCUI 884522UNII JJ768O327N

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

N427808008501 followed by a unit qualifier and the quantity

Package 27808-0085-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Dextroamphetamine sulfate oral solution is indicated in: Narcolepsy Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: Moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 27808-085

What is NDC 27808-085?
27808-085 is the product NDC for Dextroamphetamine, Dextroamphetamine sulfate 5 mg/5mL solution, listed with the FDA by Cranbury Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dextroamphetamine.
What is the active ingredient?
Dextroamphetamine sulfate.
Who is the labeler?
Cranbury Pharmaceuticals, LLC, NDC labeler code 27808. 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?
1 other product NDC are listed under this name. See all Dextroamphetamine 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DextroamphetamineDextroamphetamine sulfate 5 mg/5mLSolutionOralBryant Ranch Prepack72162-204372162-2043-02

Other NDCs under ANDA 203644

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

FDA NDC Directory listings under ANDA 203644
ProductStrengthForm · routeLabelerProduct NDC
DextroamphetamineDextroamphetamine sulfate 5 mg/5mLSolutionOralBryant Ranch Prepack72162-2043

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