FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
64376-640
11-digit product format
643760640
Labeler code
64376
Product ID
64376-640_5a130fa6-bcb0-4363-92a0-f657afc557ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate, Acetaminophen
Dosage form
SOLUTION
Route
ORAL
Labeler
Par Pharmaceutical
Application
ANDA040894
Marketing category
ANDA
Marketing start
2011-07-27
Marketing end
2021-09-30
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325 mg/15mL; mg/15mL
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
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f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
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11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
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557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
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332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
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53855190-7124-8179-f018-e792f7c27f28Product name120140508
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61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64376-640-16ML - Milliliter64376-64008b15b0c-0d5a-4929-837e-14869bf714d912012-07-24
64376-640-40ML - Milliliter64376-640fdf0f1e7-888e-4833-852a-2bc1af9dc12112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
ETHYL MALTOLINACTIVE INGREDIENTL6Q8K29L05HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
SORBITOLINACTIVE INGREDIENT506T60A25RHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
SUCROSEINACTIVE INGREDIENTC151H8M554HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
ETHYL MALTOLINACTIVE INGREDIENTL6Q8K29L05HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856940HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG in 15 mL Oral SolutionPSN21539e8e-a9b9-49ab-9134-c2cdc0a543214
856940acetaminophen 21.7 MG/ML / hydrocodone bitartrate 0.5 MG/ML Oral SolutionSCD21539e8e-a9b9-49ab-9134-c2cdc0a543214
856940acetaminophen 108 MG / hydrocodone bitartrate 2.5 MG per 5 ML Oral SolutionSY21539e8e-a9b9-49ab-9134-c2cdc0a543214
856940acetaminophen 217 MG / hydrocodone bitartrate 5 MG per 10 ML Oral SolutionSY21539e8e-a9b9-49ab-9134-c2cdc0a543214
856940acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG per 15 ML Oral SolutionSY21539e8e-a9b9-49ab-9134-c2cdc0a543214
856940APAP 21.7 MG/ML / Hydrocodone Bitartrate 0.5 MG/ML Oral SolutionSY21539e8e-a9b9-49ab-9134-c2cdc0a543214
856940HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG in 15 mL Oral SolutionPSNe1580b70-08ad-4167-95ed-aa556ea8553e2
856940acetaminophen 21.7 MG/ML / hydrocodone bitartrate 0.5 MG/ML Oral SolutionSCDe1580b70-08ad-4167-95ed-aa556ea8553e2
856940acetaminophen 108 MG / hydrocodone bitartrate 2.5 MG per 5 ML Oral SolutionSYe1580b70-08ad-4167-95ed-aa556ea8553e2
856940acetaminophen 217 MG / hydrocodone bitartrate 5 MG per 10 ML Oral SolutionSYe1580b70-08ad-4167-95ed-aa556ea8553e2
856940acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG per 15 ML Oral SolutionSYe1580b70-08ad-4167-95ed-aa556ea8553e2
856940APAP 21.7 MG/ML / Hydrocodone Bitartrate 0.5 MG/ML Oral SolutionSYe1580b70-08ad-4167-95ed-aa556ea8553e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64376-640-1664376064016473 mL in 1 BOTTLE (64376-640-16) 473 ml2011-07-272021-09-30NoNoCurrent
64376-640-4064376064040118 mL in 1 BOTTLE (64376-640-40) 118 ml2011-07-272021-09-30NoNoCurrent