HYRDROCODONE APAP

Product NDC
61919-208
11-digit product format
619190208
Labeler code
61919
Product ID
61919-208_d61ab2ea-c7bb-0b05-e053-2995a90a52e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYRDROCODONE APAP
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA201013
Marketing category
ANDA
Marketing start
2019-07-22
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
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4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
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79e1734e-f721-4d46-978a-be382f771672Product name220230110
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06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
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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332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
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47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
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61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
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d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-208-262021-01-29C16284748780-1ba0f9c33-4566-a910-e053-dadaa90a0b85HYRDROCODONE APAP
61919-208-722021-01-29C16284748780-1ba0f9c33-1d8a-a910-e053-dadaa90a0b85HYRDROCODONE APAP
61919-208-302020-01-31C16284748780-19d75b9cf-eabf-f424-e053-dadaa90a57ceHYRDROCODONE APAP
61919-208-902020-01-31C16284748780-19d75b9cf-eabf-f424-e053-dadaa90a57ceHYRDROCODONE APAP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-208-30HYRDROCODONE APAP30 in 1 BOTTLETABLET303
61919-208-72HYRDROCODONE APAP120 in 1 BOTTLETABLET1203
61919-208-90HYRDROCODONE APAP90 in 1 BOTTLETABLET903
61919-208-26HYRDROCODONE APAP26 in 1 BOTTLETABLET261

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-208-26EA - Each61919-208e0a4ca4c-b877-4c7f-b7c7-90a4a764efa012019-09-05
61919-208-60EA - Each61919-208f3518990-8d73-434e-bf40-b0629b6f90c812019-08-06
61919-208-72EA - Each61919-208a983a950-a1d0-4a83-8b97-b8ba4514450a12019-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDIRECT RX (HYRDROCODONE APAP) TABLET [DIRECT RX]2
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKDIRECT RX (HYRDROCODONE APAP) TABLET [DIRECT RX]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDIRECT RX (HYRDROCODONE APAP) TABLET [DIRECT RX]2
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7DIRECT RX (HYRDROCODONE APAP) TABLET [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIRECT RX (HYRDROCODONE APAP) TABLET [DIRECT RX]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIRECT RX (HYRDROCODONE APAP) TABLET [DIRECT RX]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDIRECT RX (HYRDROCODONE APAP) TABLET [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIRECT RX (HYRDROCODONE APAP) TABLET [DIRECT RX]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDIRECT RX (HYRDROCODONE APAP) TABLET [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIRECT RX (HYRDROCODONE APAP) TABLET [DIRECT RX]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIRECT RX (HYRDROCODONE APAP) TABLET [DIRECT RX]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDIRECT RX (HYRDROCODONE APAP) TABLET [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-208HYRDROCODONE APAP TABLET [DIRECT RX]3Legacy NDC, 2 package rows20160923_36710b35-419c-4e64-8bd1-29b81a4c8e03.zip
61919-208HYRDROCODONE APAP TABLET [DIRECT_RX]3Legacy NDC, 1 package rows20190626_8b269d2a-3d8e-9504-e053-2995a90a17a9.zip
61919-208HYRDROCODONE APAP TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190723_8e4920b4-c7f6-4cf1-e053-2a95a90a8ea5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN36710b35-419c-4e64-8bd1-29b81a4c8e033
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN8b269d2a-3d8e-9504-e053-2995a90a17a93
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD36710b35-419c-4e64-8bd1-29b81a4c8e033
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD8b269d2a-3d8e-9504-e053-2995a90a17a93
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY36710b35-419c-4e64-8bd1-29b81a4c8e033
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY8b269d2a-3d8e-9504-e053-2995a90a17a93
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN8e4920b4-c7f6-4cf1-e053-2a95a90a8ea51
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD8e4920b4-c7f6-4cf1-e053-2a95a90a8ea51
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY8e4920b4-c7f6-4cf1-e053-2a95a90a8ea51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-208-266191902082626 in 1 BOTTLEHistorical
61919-208-306191902083030 in 1 BOTTLEHistorical
61919-208-606191902086060 TABLET in 1 BOTTLE (61919-208-60) 60 tablet2019-07-220000-00-00NoNoCurrent
61919-208-7261919020872120 in 1 BOTTLEHistorical
61919-208-906191902089090 in 1 BOTTLEHistorical