Prescription drug · ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate NDC 63629-1974
Amphetamine sulfate 3.75 mg/1 + 3 more ingredients · Capsule, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-1974-1 | 6362919740163629197401 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-1974-1)Marketed from Dec 21, 2021 |
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 Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
- Generic name (nonproprietary)
- dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate
- Active ingredients
- Amphetamine sulfate — 3.75 mg/1Amphetamine aspartate monohydrate — 3.75 mg/1Dextroamphetamine sulfate — 3.75 mg/1Dextroamphetamine saccharate — 3.75 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205401
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 63629-1974_41e333aa-2ac3-43f0-89ea-8546a638db62SPL ID 41e333aa-2ac3-43f0-89ea-8546a638db62SPL set ID a628ce9e-b216-44b1-9f07-f2aff97b0139RxCUI 861223UNII 6DPV8NK46S, O1ZPV620O4, JJ768O327N, G83415V073
- 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
N463629197401followed by a unit qualifier and the quantityPackage 63629-1974-01. 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)
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules, a CNS stimulant, are indicated for the treatment of attention deficit hyperactivity disorder (ADHD). ( 1 ) • Children (ages 6-12): Efficacy was established in one 3-week outpatient, controlled trial and one analogue classroom, controlled trial in children with ADHD. ( 14 ) • Adolescents (ages 13-17): Efficacy was established in one 4-week controlled trial in adolescents with ADHD. ( 14 ) • Adults: Efficacy was established in one 4-week controlled trial in adults with ADHD. ( 14 ) 1.1 Attention Deficit Hyperactivity Disorder Dextroamphetamine saccharat…
Excerpt only. Read the full label for complete information.
About NDC 63629-1974
- What is NDC 63629-1974?
- 63629-1974 is the product NDC for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Amphetamine sulfate 3.75 mg/1 + 3 more ingredients capsule, extended release, 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 Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate.
- What is the active ingredient?
- Amphetamine sulfate, Amphetamine aspartate monohydrate, Dextroamphetamine sulfate, Dextroamphetamine saccharate.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate?
- 91 other product NDCs are listed under this name. See all Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine 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 Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate products
Other finished products listed under the same name: strengths, forms and labelers.
Other NDCs under ANDA 205401
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.