asprin and extended-release dipyridamole

Generic: asprin and extended-release dipyridamole

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

Drug Facts

Product Profile

Brand Name asprin and extended-release dipyridamole
Generic Name asprin and extended-release dipyridamole
Labeler glenmark pharmaceuticals inc., usa
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

aspirin 25 mg/1, dipyridamole 200 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-405
Product ID 68462-405_d202f375-08c4-42da-bd96-2b62d7ebe7e8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210318
Listing Expiration 2027-12-31
Marketing Start 2019-05-24

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc] platelet aggregation inhibitor [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]
Physiologic Effect
decreased prostaglandin production [pe] decreased platelet aggregation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462405
Hyphenated Format 68462-405

Supplemental Identifiers

RxCUI
259081
UPC
0368462405604
UNII
R16CO5Y76E 64ALC7F90C
NUI
N0000000160 N0000008836 M0001335 N0000175722 N0000175578 N0000008832

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 asprin and extended-release dipyridamole (source: ndc)
Generic Name asprin and extended-release dipyridamole (source: ndc)
Application Number ANDA210318 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 200 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (68462-405-30)
  • 60 CAPSULE in 1 BOTTLE (68462-405-60)
source: ndc

Packages (2)

68462-405-30 30 CAPSULE in 1 BOTTLE (68462-405-30) 68462-405-60 60 CAPSULE in 1 BOTTLE (68462-405-60)

Ingredients (2)

aspirin (25 mg/1) dipyridamole (200 mg/1)

Linked Drug Pages (1)

ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d202f375-08c4-42da-bd96-2b62d7ebe7e8", "openfda": {"nui": ["N0000000160", "N0000008836", "M0001335", "N0000175722", "N0000175578", "N0000008832"], "upc": ["0368462405604"], "unii": ["R16CO5Y76E", "64ALC7F90C"], "rxcui": ["259081"], "spl_set_id": ["467d6ce3-bc05-4aa1-87cc-3214fd628d39"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_pe": ["Decreased Prostaglandin Production [PE]", "Decreased Platelet Aggregation [PE]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]", "Platelet Aggregation Inhibitor [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68462-405-30)", "package_ndc": "68462-405-30", "marketing_start_date": "20190524"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (68462-405-60)", "package_ndc": "68462-405-60", "marketing_start_date": "20190524"}], "brand_name": "ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE", "product_id": "68462-405_d202f375-08c4-42da-bd96-2b62d7ebe7e8", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Platelet Aggregation [PE]", "Decreased Platelet Aggregation [PE]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "Platelet Aggregation Inhibitor [EPC]", "Platelet Aggregation Inhibitor [EPC]"], "product_ndc": "68462-405", "generic_name": "ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE", "active_ingredients": [{"name": "ASPIRIN", "strength": "25 mg/1"}, {"name": "DIPYRIDAMOLE", "strength": "200 mg/1"}], "application_number": "ANDA210318", "marketing_category": "ANDA", "marketing_start_date": "20190524", "listing_expiration_date": "20271231"}