Ascomp with Codeine

Product NDC
0722-6094
11-digit product format
007226094
Labeler code
0722
Product ID
0722-6094_02774411-cc86-46a1-9bb7-2ac867f9c7ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Aspirin, Cafeine, and Codeine Phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Nexgen Pharma, Inc.
Application
ANDA075231
Marketing category
ANDA
Marketing start
2001-11-30
Marketing end
0000-00-00
Substance
BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE
Active strength
50 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Barbiturates [CS],Barbiturate [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],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
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20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
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9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
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30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0722-6094-01Ascomp with Codeine100 in 1 BOTTLECAPSULE10011
0722-6094-05Ascomp with Codeine500 in 1 BOTTLECAPSULE50011

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0722-6094ASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFEINE, AND CODEINE PHOSPHATE) CAPSULE [NEXGEN PHARMA, INC.]11Legacy NDC, 2 package rows20200214_ca3fe6e9-21ad-4fba-a602-e1c364cf3981.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994239Ascomp with Codeine 50 MG / 325 MG / 40 MG / 30 MG Oral CapsulePSNca3fe6e9-21ad-4fba-a602-e1c364cf398111
994237butalbital 50 MG / aspirin 325 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsulePSNca3fe6e9-21ad-4fba-a602-e1c364cf398111
994239aspirin 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule [Ascomp]SBDca3fe6e9-21ad-4fba-a602-e1c364cf398111
994237aspirin 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsuleSCDca3fe6e9-21ad-4fba-a602-e1c364cf398111
994237ASA 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsuleSYca3fe6e9-21ad-4fba-a602-e1c364cf398111
994239ASA 325 MG / butalbital 50 MG / Caffeine 40 MG / Codeine Phosphate 30 MG Oral Capsule [Ascomp]SYca3fe6e9-21ad-4fba-a602-e1c364cf398111
994239Ascomp with Codeine (ASA 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG) Oral CapsuleSYca3fe6e9-21ad-4fba-a602-e1c364cf398111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0722-6094-0100722609401100 CAPSULE in 1 BOTTLE (0722-6094-01) 100 capsule2001-11-300000-00-00NoNoCurrent
0722-6094-0500722609405500 CAPSULE in 1 BOTTLE (0722-6094-05) 500 capsule2001-11-300000-00-00NoNoCurrent