felodipine

Generic: felodipine

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name felodipine
Generic Name felodipine
Labeler torrent pharmaceuticals limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

felodipine 10 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-134
Product ID 13668-134_788121c3-8ac5-4592-b1c7-55466b849cce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202170
Listing Expiration 2027-12-31
Marketing Start 2011-11-28

Pharmacologic Class

Established (EPC)
dihydropyridine calcium channel blocker [epc]
Mechanism of Action
calcium channel antagonists [moa]
Chemical Structure
dihydropyridines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13668134
Hyphenated Format 13668-134

Supplemental Identifiers

RxCUI
402695 402696 402698
UPC
0313668132304 0313668134308
UNII
OL961R6O2C
NUI
N0000000069 N0000175421 M0006414

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 felodipine (source: ndc)
Generic Name felodipine (source: ndc)
Application Number ANDA202170 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-05)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-10)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-30)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-90)
source: ndc

Packages (5)

13668-134-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-01) 13668-134-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-05) 13668-134-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-10) 13668-134-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-30) 13668-134-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-90)

Ingredients (1)

felodipine (10 mg/1)

Linked Drug Pages (1)

Felodipine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "788121c3-8ac5-4592-b1c7-55466b849cce", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "upc": ["0313668132304", "0313668134308"], "unii": ["OL961R6O2C"], "rxcui": ["402695", "402696", "402698"], "spl_set_id": ["60fb803e-ccf7-46f2-b506-e157ce440f87"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-01)", "package_ndc": "13668-134-01", "marketing_start_date": "20111128"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-05)", "package_ndc": "13668-134-05", "marketing_start_date": "20111128"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-10)", "package_ndc": "13668-134-10", "marketing_start_date": "20111128"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-30)", "package_ndc": "13668-134-30", "marketing_start_date": "20111128"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-134-90)", "package_ndc": "13668-134-90", "marketing_start_date": "20111128"}], "brand_name": "Felodipine", "product_id": "13668-134_788121c3-8ac5-4592-b1c7-55466b849cce", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "13668-134", "generic_name": "Felodipine", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Felodipine", "active_ingredients": [{"name": "FELODIPINE", "strength": "10 mg/1"}], "application_number": "ANDA202170", "marketing_category": "ANDA", "marketing_start_date": "20111128", "listing_expiration_date": "20271231"}