alprazolam

Generic: alprazolam

Labeler: natco pharma usa llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alprazolam
Generic Name alprazolam
Labeler natco pharma usa llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

alprazolam .5 mg/1

Manufacturer
Natco Pharma USA LLC

Identifiers & Regulatory

Product NDC 69339-200
Product ID 69339-200_885d0fec-f1a6-42f4-8617-1d048cb15ee9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200739
DEA Schedule civ
Listing Expiration 2027-12-31
Marketing Start 2023-07-28

Pharmacologic Class

Established (EPC)
benzodiazepine [epc]
Chemical Structure
benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69339200
Hyphenated Format 69339-200

Supplemental Identifiers

RxCUI
197321 197322 308047 308048
UPC
0369339202012 0369339199107 0369339199053 0369339199015 0369339200018 0369339201053 0369339200056 0369339201107 0369339202104 0369339202050 0369339200100 0369339201015
UNII
YU55MQ3IZY
NUI
N0000175694 M0002356

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 alprazolam (source: ndc)
Generic Name alprazolam (source: ndc)
Application Number ANDA200739 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69339-200-01)
  • 500 TABLET in 1 BOTTLE (69339-200-05)
  • 1000 TABLET in 1 BOTTLE (69339-200-10)
source: ndc

Packages (3)

69339-200-01 100 TABLET in 1 BOTTLE (69339-200-01) 69339-200-05 500 TABLET in 1 BOTTLE (69339-200-05) 69339-200-10 1000 TABLET in 1 BOTTLE (69339-200-10)

Ingredients (1)

alprazolam (.5 mg/1)

Linked Drug Pages (1)

Alprazolam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "885d0fec-f1a6-42f4-8617-1d048cb15ee9", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0369339202012", "0369339199107", "0369339199053", "0369339199015", "0369339200018", "0369339201053", "0369339200056", "0369339201107", "0369339202104", "0369339202050", "0369339200100", "0369339201015"], "unii": ["YU55MQ3IZY"], "rxcui": ["197321", "197322", "308047", "308048"], "spl_set_id": ["b3c55877-2538-4892-bdb1-d618c643d29c"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Natco Pharma USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69339-200-01)", "package_ndc": "69339-200-01", "marketing_start_date": "20230728"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69339-200-05)", "package_ndc": "69339-200-05", "marketing_start_date": "20230728"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (69339-200-10)", "package_ndc": "69339-200-10", "marketing_start_date": "20230728"}], "brand_name": "Alprazolam", "product_id": "69339-200_885d0fec-f1a6-42f4-8617-1d048cb15ee9", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "69339-200", "dea_schedule": "CIV", "generic_name": "Alprazolam", "labeler_name": "Natco Pharma USA LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alprazolam", "active_ingredients": [{"name": "ALPRAZOLAM", "strength": ".5 mg/1"}], "application_number": "ANDA200739", "marketing_category": "ANDA", "marketing_start_date": "20230728", "listing_expiration_date": "20271231"}