orphenadrine citrate, aspirin and caffeine (71993-304)

Drug Facts

Product Profile

Brand Name orphenadrine citrate, aspirin and caffeine

Generic Name orphenadrine citrate, aspirin and caffeine

Labeler atland pharmaceuticals, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Atland Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 71993-304

Product ID 71993-304_414d35d9-b9a2-d717-e063-6294a90a9415

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA075141

Listing Expiration 2026-12-31

Marketing Start 2022-03-18

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 71993304

Hyphenated Format 71993-304

Supplemental Identifiers

RxCUI

994528

UPC

0371993304605

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 orphenadrine citrate, aspirin and caffeine (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 (71993-304-60)

source: ndc

Packages (1)

71993-304-60 60 TABLET in 1 BOTTLE, PLASTIC (71993-304-60)

Ingredients (3)

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

Linked Drug Pages (1)

Orphenadrine Citrate, Aspirin and Caffeine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "414d35d9-b9a2-d717-e063-6294a90a9415", "openfda": {"nui": ["N0000000160", "N0000008836", "M0001335", "N0000175722", "N0000175578", "N0000008832", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "upc": ["0371993304605"], "unii": ["R16CO5Y76E", "3G6A5W338E", "X0A40N8I4S"], "rxcui": ["994528"], "spl_set_id": ["61ca2af1-081c-411c-90ce-ec6d9e3157b2"], "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": ["Atland Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (71993-304-60)", "package_ndc": "71993-304-60", "marketing_start_date": "20220318"}], "brand_name": "Orphenadrine Citrate, Aspirin and Caffeine", "product_id": "71993-304_414d35d9-b9a2-d717-e063-6294a90a9415", "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": "71993-304", "generic_name": "Orphenadrine Citrate, Aspirin and Caffeine", "labeler_name": "Atland Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Orphenadrine Citrate, Aspirin and Caffeine", "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": "20220318", "listing_expiration_date": "20261231"}