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NDC 00115-1682-01 Dexmethylphenidate hydrochloride 5 mg/1 Details
Dexmethylphenidate hydrochloride 5 mg/1
Dexmethylphenidate hydrochloride is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals of New York LLC. The primary component is DEXMETHYLPHENIDATE HYDROCHLORIDE.
Product Information
NDC | 00115-1682 |
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Product ID | 0115-1682_d431fe33-4a29-4d90-9d0d-38f146aedbd6 |
Associated GPIs | 61400016107020 |
GCN Sequence Number | 059190 |
GCN Sequence Number Description | dexmethylphenidate HCl CPBP 50-50 5 MG ORAL |
HIC3 | H2V |
HIC3 Description | TX FOR ATTENTION DEFICIT-HYPERACT(ADHD)/NARCOLEPSY |
GCN | 24733 |
HICL Sequence Number | 022987 |
HICL Sequence Number Description | DEXMETHYLPHENIDATE HCL |
Brand/Generic | Generic |
Proprietary Name | Dexmethylphenidate hydrochloride |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Dexmethylphenidate hydrochloride |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | CAPSULE, EXTENDED RELEASE |
Route | ORAL |
Active Ingredient Strength | 5 |
Active Ingredient Units | mg/1 |
Substance Name | DEXMETHYLPHENIDATE HYDROCHLORIDE |
Labeler Name | Amneal Pharmaceuticals of New York LLC |
Pharmaceutical Class | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
DEA Schedule | CII |
Marketing Category | ANDA |
Application Number | ANDA079108 |
Listing Certified Through | 2024-12-31 |
Package
NDC 00115-1682-01 (00115168201)
NDC Package Code | 0115-1682-01 |
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Billing NDC | 00115168201 |
Package | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1682-01) |
Marketing Start Date | 2015-08-06 |
NDC Exclude Flag | N |
Pricing Information | N/A |