Prescription drug · ANDA
Dextroamphetamine Sulfate NDC 0555-0953
Dextroamphetamine sulfate 10 mg/1 · Tablet · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0555-0953-02 | 00555095302 | 100 TABLET in 1 BOTTLE (0555-0953-02)Marketed from Feb 12, 2001 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0555
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040361
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 0555-0953_05934bca-3ed9-4ce3-ba1d-2063930aad63SPL ID 05934bca-3ed9-4ce3-ba1d-2063930aad63SPL set ID ec2d13f3-d14f-47e4-abe9-7763f95a8e94RxCUI 884385, 884386UNII 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
N400555095302followed by a unit qualifier and the quantityPackage 00555-0953-02. 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 Tablets are indicated for: Narcolepsy . 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. Nonlocalizing (soft)…
Excerpt only. Read the full label for complete information.
About NDC 0555-0953
- What is NDC 0555-0953?
- 0555-0953 is the product NDC for Dextroamphetamine Sulfate, Dextroamphetamine sulfate 10 mg/1 tablet, listed with the FDA by Teva Pharmaceuticals USA, 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?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0555. 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 040361
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 5 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0555-0952 |