Prescription drug · ANDA
Dextroamphetamine NDC 27808-085
Dextroamphetamine sulfate 5 mg/5mL · Solution · Oral · Cranbury Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 27808-085-01 | 2780800850127808008501 | 473 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
- 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
N427808008501followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Dextroamphetamine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dextroamphetamine | Dextroamphetamine sulfate 5 mg/5mL | SolutionOral | Bryant Ranch Prepack | 72162-2043 | 72162-2043-02 |
Other NDCs under ANDA 203644
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dextroamphetamine | Dextroamphetamine sulfate 5 mg/5mL | SolutionOral | Bryant Ranch Prepack | 72162-2043 |