dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate

Generic: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate

Labeler: teva pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
Generic Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
Labeler teva pharmaceuticals, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

amphetamine aspartate monohydrate 12.5 mg/1, amphetamine sulfate 12.5 mg/1, dextroamphetamine saccharate 12.5 mg/1, dextroamphetamine sulfate 12.5 mg/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-3686
Product ID 0480-3686_071657b6-4f64-48c9-ac5f-4cb20d9b7430
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210876
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2023-10-10

Pharmacologic Class

Classes
central nervous system stimulant [epc] central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04803686
Hyphenated Format 0480-3686

Supplemental Identifiers

RxCUI
1927610 1927617 1927630 1927637
UPC
0304803683010 0304803684017 0304803686011 0304803685014
UNII
O1ZPV620O4 6DPV8NK46S G83415V073 JJ768O327N

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate (source: ndc)
Generic Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate (source: ndc)
Application Number ANDA210876 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3686-01)
source: ndc

Packages (1)

0480-3686-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3686-01)

Ingredients (4)

amphetamine aspartate monohydrate (12.5 mg/1) amphetamine sulfate (12.5 mg/1) dextroamphetamine saccharate (12.5 mg/1) dextroamphetamine sulfate (12.5 mg/1)

Linked Drug Pages (1)

dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "071657b6-4f64-48c9-ac5f-4cb20d9b7430", "openfda": {"upc": ["0304803683010", "0304803684017", "0304803686011", "0304803685014"], "unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["1927610", "1927617", "1927630", "1927637"], "spl_set_id": ["5e84ef60-3050-40d9-9f14-66b85d289e17"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3686-01)", "package_ndc": "0480-3686-01", "marketing_start_date": "20231010"}], "brand_name": "dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate", "product_id": "0480-3686_071657b6-4f64-48c9-ac5f-4cb20d9b7430", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]", "Central Nervous System Stimulation [PE]", "Central Nervous System Stimulation [PE]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0480-3686", "dea_schedule": "CII", "generic_name": "dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate", "active_ingredients": [{"name": "AMPHETAMINE ASPARTATE MONOHYDRATE", "strength": "12.5 mg/1"}, {"name": "AMPHETAMINE SULFATE", "strength": "12.5 mg/1"}, {"name": "DEXTROAMPHETAMINE SACCHARATE", "strength": "12.5 mg/1"}, {"name": "DEXTROAMPHETAMINE SULFATE", "strength": "12.5 mg/1"}], "application_number": "ANDA210876", "marketing_category": "ANDA", "marketing_start_date": "20231010", "listing_expiration_date": "20271231"}