sdamlo

Generic: amlodipine

Labeler: pangea pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sdamlo
Generic Name amlodipine
Labeler pangea pharmaceuticals, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/10mg

Manufacturer
Pangea Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 81279-135
Product ID 81279-135_4b0523be-cded-6306-e063-6394a90a8a12
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA219531
Listing Expiration 2027-12-31
Marketing Start 2026-02-05

Pharmacologic Class

Classes
calcium channel antagonists [moa] calcium channel blocker [epc] cytochrome p450 3a inhibitors [moa] dihydropyridine calcium channel blocker [epc] dihydropyridines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81279135
Hyphenated Format 81279-135

Supplemental Identifiers

RxCUI
2726058 2726064 2726065 2726067 2726068 2726070
UNII
864V2Q084H

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 sdamlo (source: ndc)
Generic Name amlodipine (source: ndc)
Application Number NDA219531 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/10mg
source: ndc
Packaging
  • 10 BOTTLE in 1 CARTON (81279-135-10) / 10 mg in 1 BOTTLE
source: ndc

Packages (1)

81279-135-10 10 BOTTLE in 1 CARTON (81279-135-10) / 10 mg in 1 BOTTLE

Ingredients (1)

amlodipine besylate (10 mg/10mg)

Linked Drug Pages (1)

Sdamlo ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4b0523be-cded-6306-e063-6394a90a8a12", "openfda": {"unii": ["864V2Q084H"], "rxcui": ["2726058", "2726064", "2726065", "2726067", "2726068", "2726070"], "spl_set_id": ["886a7f97-60a4-4206-a6c7-5206069ed487"], "manufacturer_name": ["Pangea Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BOTTLE in 1 CARTON (81279-135-10)  / 10 mg in 1 BOTTLE", "package_ndc": "81279-135-10", "marketing_start_date": "20260205"}], "brand_name": "Sdamlo", "product_id": "81279-135_4b0523be-cded-6306-e063-6394a90a8a12", "dosage_form": "SOLUTION", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "81279-135", "generic_name": "amlodipine", "labeler_name": "Pangea Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sdamlo", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/10mg"}], "application_number": "NDA219531", "marketing_category": "NDA", "marketing_start_date": "20260205", "listing_expiration_date": "20271231"}