norgesic

Generic: orphenadrine citrate, aspirin and caffeine

Labeler: galt pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name norgesic
Generic Name orphenadrine citrate, aspirin and caffeine
Labeler galt pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

aspirin 385 mg/1, caffeine 30 mg/1, orphenadrine citrate 25 mg/1

Manufacturer
Galt Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 61825-305
Product ID 61825-305_47da9e12-c9c2-d80e-e063-6294a90a86aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075141
Listing Expiration 2027-12-31
Marketing Start 2022-05-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61825305
Hyphenated Format 61825-305

Supplemental Identifiers

RxCUI
994528 994530
UNII
R16CO5Y76E 3G6A5W338E X0A40N8I4S
NUI
N0000000160 N0000008836 M0001335 N0000175722 N0000175578 N0000008832 N0000175739 N0000175729 N0000175790 M0023046

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 norgesic (source: ndc)
Generic Name orphenadrine citrate, aspirin and caffeine (source: ndc)
Application Number ANDA075141 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 385 mg/1
  • 30 mg/1
  • 25 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE, PLASTIC (61825-305-60)
source: ndc

Packages (1)

61825-305-60 60 TABLET in 1 BOTTLE, PLASTIC (61825-305-60)

Ingredients (3)

aspirin (385 mg/1) caffeine (30 mg/1) orphenadrine citrate (25 mg/1)

Linked Drug Pages (1)

Norgesic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47da9e12-c9c2-d80e-e063-6294a90a86aa", "openfda": {"nui": ["N0000000160", "N0000008836", "M0001335", "N0000175722", "N0000175578", "N0000008832", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["R16CO5Y76E", "3G6A5W338E", "X0A40N8I4S"], "rxcui": ["994528", "994530"], "spl_set_id": ["be2761bc-e537-4039-846a-2ffa3d8b2afc"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]", "Xanthines [CS]"], "pharm_class_pe": ["Decreased Prostaglandin Production [PE]", "Decreased Platelet Aggregation [PE]", "Central Nervous System Stimulation [PE]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]", "Platelet Aggregation Inhibitor [EPC]", "Central Nervous System Stimulant [EPC]", "Methylxanthine [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Galt Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (61825-305-60)", "package_ndc": "61825-305-60", "marketing_start_date": "20220516"}], "brand_name": "Norgesic", "product_id": "61825-305_47da9e12-c9c2-d80e-e063-6294a90a86aa", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]", "Centrally-mediated Muscle Relaxation [PE]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Platelet Aggregation [PE]", "Decreased Prostaglandin Production [PE]", "Methylxanthine [EPC]", "Muscle Relaxant [EPC]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "Platelet Aggregation Inhibitor [EPC]", "Xanthines [CS]"], "product_ndc": "61825-305", "generic_name": "Orphenadrine Citrate, Aspirin and Caffeine", "labeler_name": "Galt Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norgesic", "active_ingredients": [{"name": "ASPIRIN", "strength": "385 mg/1"}, {"name": "CAFFEINE", "strength": "30 mg/1"}, {"name": "ORPHENADRINE CITRATE", "strength": "25 mg/1"}], "application_number": "ANDA075141", "marketing_category": "ANDA", "marketing_start_date": "20220516", "listing_expiration_date": "20271231"}