FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
27808-035
11-digit product format
278080035
Labeler code
27808
Product ID
27808-035_cf89ef14-b1bb-4341-8911-892ce7d157c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Cranbury Pharmaceuticals, LLC
Application
ANDA202214
Marketing category
ANDA
Marketing start
2014-10-06
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 5 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocodone Bitartrate and Acetaminophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
HYDROCODONE BITARTRATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNO70W886KK, 362O9ITL9D
Rxcui856999, 857002, 857005

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
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06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
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53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
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20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
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7855f8e3-562e-4273-8b79-0059c07a71f7Product name120170901
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332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27808-035-01Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLE, PLASTICTABLET10036
27808-035-02Hydrocodone Bitartrate and Acetaminophen500 in 1 BOTTLE, PLASTICTABLET50036
27808-035-03Hydrocodone Bitartrate and Acetaminophen1000 in 1 BOTTLE, PLASTICTABLET100036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27808-035-01EA - Each27808-035ba7ddbfb-e188-4d68-bf6d-df59412ebd8312014-07-02
27808-035-02EA - Each27808-035ff8f5d36-4907-469e-a93e-1854559b00f712014-07-02
27808-035-03EA - Each27808-035a6f363b0-3c5a-468f-9466-e9142942016812015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [TRIS PHARMA INC]5
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [TRIS PHARMA INC]5
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [TRIS PHARMA INC]5
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [TRIS PHARMA INC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [TRIS PHARMA INC]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [TRIS PHARMA INC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [TRIS PHARMA INC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [TRIS PHARMA INC]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [TRIS PHARMA INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27808-035HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [CRANBURY PHARMACEUTICALS, LLC]32Current NDC, Legacy NDC, 3 package rows20250130_d4caec6d-4af2-4f1c-9add-c0c948b83b16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN8e99994a-83b4-4b1f-9654-4ae373bf2c4d107
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD8e99994a-83b4-4b1f-9654-4ae373bf2c4d107
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY8e99994a-83b4-4b1f-9654-4ae373bf2c4d107
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN2ad2d00e-3796-4605-852f-a3d64d5ef09f106
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD2ad2d00e-3796-4605-852f-a3d64d5ef09f106
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY2ad2d00e-3796-4605-852f-a3d64d5ef09f106
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNc9f7f4c1-c4e2-4f9b-bb02-72fb35eb4325105
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNde918a56-c43e-44c7-941c-f9dd581845a7105
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDc9f7f4c1-c4e2-4f9b-bb02-72fb35eb4325105
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDde918a56-c43e-44c7-941c-f9dd581845a7105
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYc9f7f4c1-c4e2-4f9b-bb02-72fb35eb4325105
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYde918a56-c43e-44c7-941c-f9dd581845a7105
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNa3cbf0c1-b589-4e4a-b355-01bddb7e4955104
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDa3cbf0c1-b589-4e4a-b355-01bddb7e4955104
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYa3cbf0c1-b589-4e4a-b355-01bddb7e4955104
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN36bf5e37-9202-4288-8354-9d123fb692d3100
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD36bf5e37-9202-4288-8354-9d123fb692d3100
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY36bf5e37-9202-4288-8354-9d123fb692d3100
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNd4caec6d-4af2-4f1c-9add-c0c948b83b1636
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNd4caec6d-4af2-4f1c-9add-c0c948b83b1636
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSNd4caec6d-4af2-4f1c-9add-c0c948b83b1636
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDd4caec6d-4af2-4f1c-9add-c0c948b83b1636
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDd4caec6d-4af2-4f1c-9add-c0c948b83b1636
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDd4caec6d-4af2-4f1c-9add-c0c948b83b1636
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYd4caec6d-4af2-4f1c-9add-c0c948b83b1636
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYd4caec6d-4af2-4f1c-9add-c0c948b83b1636
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSYd4caec6d-4af2-4f1c-9add-c0c948b83b1636
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN68699eda-a72a-6b20-e053-2991aa0a89b55
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD68699eda-a72a-6b20-e053-2991aa0a89b55
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY68699eda-a72a-6b20-e053-2991aa0a89b55
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNba7d27eb-952d-4e99-95b9-5b0b2f85794b3
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNba7d27eb-952d-4e99-95b9-5b0b2f85794b3
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSNba7d27eb-952d-4e99-95b9-5b0b2f85794b3
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDba7d27eb-952d-4e99-95b9-5b0b2f85794b3
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDba7d27eb-952d-4e99-95b9-5b0b2f85794b3
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDba7d27eb-952d-4e99-95b9-5b0b2f85794b3
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYba7d27eb-952d-4e99-95b9-5b0b2f85794b3
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYba7d27eb-952d-4e99-95b9-5b0b2f85794b3
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSYba7d27eb-952d-4e99-95b9-5b0b2f85794b3
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN806a981f-85ff-4e58-8ff0-7ab02ed2e5c12
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD806a981f-85ff-4e58-8ff0-7ab02ed2e5c12
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY806a981f-85ff-4e58-8ff0-7ab02ed2e5c12
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN425258b6-72d7-e9b5-e063-6394a90a3fc71
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN226765e9-a6b1-22b6-e063-6394a90a364e1
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD425258b6-72d7-e9b5-e063-6394a90a3fc71
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD226765e9-a6b1-22b6-e063-6394a90a364e1
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY226765e9-a6b1-22b6-e063-6394a90a364e1
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY425258b6-72d7-e9b5-e063-6394a90a3fc71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27808-035-0127808003501100 TABLET in 1 BOTTLE, PLASTIC (27808-035-01) 100 tablet2014-10-060000-00-00NoNoCurrent
27808-035-0227808003502500 TABLET in 1 BOTTLE, PLASTIC (27808-035-02) 500 tablet2014-10-060000-00-00NoNoCurrent
27808-035-03278080035031000 TABLET in 1 BOTTLE, PLASTIC (27808-035-03) 1000 tablet2014-10-060000-00-00NoNoCurrent