Prescription drug · ANDA
Dextroamphetamine Sulfate NDC 43386-870
Dextroamphetamine sulfate 5 mg/1 · Tablet · Oral · Lupin Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43386-870-01 | 43386087001 | 100 TABLET in 1 BOTTLE (43386-870-01)Marketed from Apr 25, 2016 |
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
- Tablet
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals,Inc.NDC labeler code 43386
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204330
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 43386-870_fe1d7b03-a5d0-4a7c-99ad-7aca6edb5d02SPL ID fe1d7b03-a5d0-4a7c-99ad-7aca6edb5d02SPL set ID 9aea6b7c-729c-484d-b625-c3591b63b350RxCUI 884385, 884386UNII JJ768O327NUPC 0343386871018, 0343386870035
- 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
N443386087001followed by a unit qualifier and the quantityPackage 43386-0870-01. 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 Tablets USP are indicated for: 1. Narcolepsy. 2. Attention Deficit Disorder with Hyperactivity , as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 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. Nonlocaliz…
Excerpt only. Read the full label for complete information.
About NDC 43386-870
- What is NDC 43386-870?
- 43386-870 is the product NDC for Dextroamphetamine Sulfate, Dextroamphetamine sulfate 5 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals,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?
- Lupin Pharmaceuticals,Inc., NDC labeler code 43386. 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.
Related NDCs: other Dextroamphetamine Sulfate 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 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 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 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 | Wilshire Pharmaceuticals, Inc. | 52536-515 | 52536-0515-03 |
Other NDCs under ANDA 204330
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 Sulfate | Dextroamphetamine sulfate 10 mg/1 | TabletOral | Lupin Pharmaceuticals,Inc. | 43386-871 |