Prescription drug · ANDA
Dextroamphetamine NDC 72162-2043
Dextroamphetamine sulfate 5 mg/5mL · Solution · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2043-2 | 7216220430272162204302 | 473 mL in 1 BOTTLE, PLASTIC (72162-2043-2)Marketed from Apr 3, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch PrepackNDC labeler code 72162
- 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 72162-2043_9dcba5a8-b4ee-4e3c-a0be-3587072a4c5aSPL ID 9dcba5a8-b4ee-4e3c-a0be-3587072a4c5aSPL set ID 76da9845-2ce1-49a5-9bf3-6a550d623172RxCUI 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
N472162204302followed by a unit qualifier and the quantityPackage 72162-2043-02. 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 72162-2043
- What is NDC 72162-2043?
- 72162-2043 is the product NDC for Dextroamphetamine, Dextroamphetamine sulfate 5 mg/5mL solution, listed with the FDA by Bryant Ranch Prepack. 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?
- Bryant Ranch Prepack, NDC labeler code 72162. 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 | Cranbury Pharmaceuticals, LLC | 27808-085 | 27808-0085-01 |
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 | Cranbury Pharmaceuticals, LLC | 27808-085 |