NDC 50991-999

Norgesic Forte

Orphenadrine Citrate, Aspirin And Caffeine

Norgesic Forte is a Oral Tablet, Multilayer in the Human Prescription Drug category. It is labeled and distributed by Poly Pharmaceuticals, Inc.. The primary component is Orphenadrine Citrate; Aspirin; Caffeine.

• Product ID: 50991-999_85a3b808-b477-f2f0-e053-2a91aa0af21f
• NDC: 50991-999
• Product Type: Human Prescription Drug
• Proprietary Name: Norgesic Forte
• Generic Name: Orphenadrine Citrate, Aspirin And Caffeine
• Dosage Form: Tablet, Multilayer
• Route of Administration: ORAL
• Marketing Start Date: 2019-04-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075141
• Labeler Name: Poly Pharmaceuticals, Inc.
• Substance Name: ORPHENADRINE CITRATE; ASPIRIN; CAFFEINE
• Active Ingredient Strength: 50 mg/1; mg/1; mg/1
• Pharm Classes: Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50991-999-60

60 TABLET, MULTILAYER in 1 BOTTLE (50991-999-60)

• Marketing Start Date: 2019-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50991-999-60 [50991099960]

Norgesic Forte TABLET, MULTILAYER

• Marketing Category: ANDA
• Application Number: ANDA075141
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-04-01

Drug Details

Active Ingredients

Ingredient	Strength
ORPHENADRINE CITRATE	50 mg/1

OpenFDA Data

• SPL SET ID: 85a3b808-b476-f2f0-e053-2a91aa0af21f
• Manufacturer:
  • Poly Pharmaceuticals, Inc.
• UNII:
  • R16CO5Y76E
  • 3G6A5W338E
  • X0A40N8I4S
• Pharm Class PE:
  • Decreased Prostaglandin Production [PE]
  • Decreased Platelet Aggregation [PE]
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • Platelet Aggregation Inhibitor [EPC]
• NUI Code:
  • N0000008832
  • N0000008836
  • N0000175721
  • N0000000160
  • N0000175578
  • N0000175722

Pharmacological Class

• Centrally-mediated Muscle Relaxation [PE]
• Muscle Relaxant [EPC]
• Cyclooxygenase Inhibitors [MoA]
• Decreased Prostaglandin Production [PE]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]
• Platelet Aggregation Inhibitor [EPC]
• Decreased Platelet Aggregation [PE]
• Central Nervous System Stimulant [EPC]
• Methylxanthine [EPC]
• Xanthines [CS]
• Central Nervous System Stimulation [PE]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]
• Centrally-mediated Muscle Relaxation [PE]
• Muscle Relaxant [EPC]
• Platelet Aggregation Inhibitor [EPC]
• Decreased Platelet Aggregation [PE]
• Cyclooxygenase Inhibitors [MoA]
• Decreased Prostaglandin Production [PE]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]
• Nonsteroidal Anti-inflammatory Drug [EPC]
• Central Nervous System Stimulant [EPC]
• Methylxanthine [EPC]
• Xanthines [CS]
• Central Nervous System Stimulation [PE]

NDC Crossover Matching brand name "Norgesic Forte" or generic name "Orphenadrine Citrate, Aspirin And Caffeine"

NDC	Brand Name	Generic Name
50991-999	Norgesic Forte	Orphenadrine Citrate, Aspirin and Caffeine
61825-305	Norgesic	Orphenadrine Citrate, Aspirin and Caffeine
21695-726	Orphenadrine Citrate, Aspirin and Caffeine	Orphenadrine Citrate, Aspirin and Caffeine
71993-304	Orphenadrine Citrate, Aspirin and Caffeine	Orphenadrine Citrate, Aspirin and Caffeine
71993-999	Orphenadrine Citrate, Aspirin and Caffeine	Orphenadrine Citrate, Aspirin and Caffeine
74157-999	Orphenadrine Citrate, Aspirin and Caffeine	orphenadrine citrate, aspirin and caffeine
61825-302	ORPHENGESIC FORTE	Orphenadrine Citrate, Aspirin and Caffeine
61825-999	Orphengesic Forte	Orphenadrine Citrate, Aspirin and Caffeine