sildenafil

Generic: sildenafil citrate

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

Drug Facts

Product Profile

Brand Name sildenafil
Generic Name sildenafil citrate
Labeler ani pharmaceuticals, inc.
Dosage Form FOR SUSPENSION
Routes
ORAL
Active Ingredients

sildenafil citrate 10 mg/mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-168
Product ID 70954-168_7e36fae8-7fbe-44fe-a951-66f18f1b3fe1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212260
Listing Expiration 2026-12-31
Marketing Start 2019-05-31

Pharmacologic Class

Classes
phosphodiesterase 5 inhibitor [epc] phosphodiesterase 5 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954168
Hyphenated Format 70954-168

Supplemental Identifiers

RxCUI
1307427
UPC
0370954168102
UNII
BW9B0ZE037

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 sildenafil (source: ndc)
Generic Name sildenafil citrate (source: ndc)
Application Number ANDA212260 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70954-168-10) / 112 mL in 1 BOTTLE
source: ndc

Packages (1)

70954-168-10 1 BOTTLE in 1 CARTON (70954-168-10) / 112 mL in 1 BOTTLE

Ingredients (1)

sildenafil citrate (10 mg/mL)

Linked Drug Pages (1)

Sildenafil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7e36fae8-7fbe-44fe-a951-66f18f1b3fe1", "openfda": {"upc": ["0370954168102"], "unii": ["BW9B0ZE037"], "rxcui": ["1307427"], "spl_set_id": ["083da718-e934-4941-b083-a19b4ebe3935"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70954-168-10)  / 112 mL in 1 BOTTLE", "package_ndc": "70954-168-10", "marketing_start_date": "20190531"}], "brand_name": "Sildenafil", "product_id": "70954-168_7e36fae8-7fbe-44fe-a951-66f18f1b3fe1", "dosage_form": "FOR SUSPENSION", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "70954-168", "generic_name": "Sildenafil citrate", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sildenafil", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "10 mg/mL"}], "application_number": "ANDA212260", "marketing_category": "ANDA", "marketing_start_date": "20190531", "listing_expiration_date": "20261231"}