FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
13107-019
11-digit product format
131070019
Labeler code
13107
Product ID
13107-019_7f417649-a59e-4737-9535-ef865ab1f076
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Aurolife Pharma, LLC
Application
ANDA201013
Marketing category
ANDA
Marketing start
2012-04-11
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
Unii362O9ITL9D, NO70W886KK
Rxcui856999, 857002, 857005

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
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4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
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20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
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
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
7855f8e3-562e-4273-8b79-0059c07a71f7Product name120170901
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
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b654f2d9-ebeb-451d-96ee-22f583344623Product name120170424
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23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product 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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13107-019-01Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLETABLET10019
13107-019-05Hydrocodone Bitartrate and Acetaminophen500 in 1 BOTTLETABLET50019
13107-019-30Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET3019
13107-019-99Hydrocodone Bitartrate and Acetaminophen1000 in 1 BOTTLETABLET100019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-019-01EA - Each13107-019dfc458cc-c77a-47ee-b80b-84121521f7b012013-02-13
13107-019-05EA - Each13107-019891a8b86-3918-4d96-a1d6-8448732ccb3e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]3
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]3
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA LLC]3
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-019HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA, LLC]17Current NDC, Legacy NDC, 4 package rows20240702_60f43308-1deb-4f05-8f17-aa49ebdcf498.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN60f43308-1deb-4f05-8f17-aa49ebdcf49819
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN60f43308-1deb-4f05-8f17-aa49ebdcf49819
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN60f43308-1deb-4f05-8f17-aa49ebdcf49819
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD60f43308-1deb-4f05-8f17-aa49ebdcf49819
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD60f43308-1deb-4f05-8f17-aa49ebdcf49819
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD60f43308-1deb-4f05-8f17-aa49ebdcf49819
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY60f43308-1deb-4f05-8f17-aa49ebdcf49819
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY60f43308-1deb-4f05-8f17-aa49ebdcf49819
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY60f43308-1deb-4f05-8f17-aa49ebdcf49819
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNbfeb838d-f963-490c-9dcc-c729ea779b5214
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN2dee148f-75f3-49c7-8de6-a9aba70db72814
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD2dee148f-75f3-49c7-8de6-a9aba70db72814
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDbfeb838d-f963-490c-9dcc-c729ea779b5214
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY2dee148f-75f3-49c7-8de6-a9aba70db72814
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYbfeb838d-f963-490c-9dcc-c729ea779b5214
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNa4fef038-fbe6-2d07-e053-2995a90aa7a67
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDa4fef038-fbe6-2d07-e053-2995a90aa7a67
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYa4fef038-fbe6-2d07-e053-2995a90aa7a67
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN82b24978-8b15-43a9-b5b0-3313ed2a73c26
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD82b24978-8b15-43a9-b5b0-3313ed2a73c26
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY82b24978-8b15-43a9-b5b0-3313ed2a73c26
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN8592e901-9353-6fb6-e053-2a91aa0ad33b5
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD8592e901-9353-6fb6-e053-2a91aa0ad33b5
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY8592e901-9353-6fb6-e053-2a91aa0ad33b5
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNd8d44758-d9a9-45dc-854d-8c30a52fa9554
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNd8d44758-d9a9-45dc-854d-8c30a52fa9554
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSNd8d44758-d9a9-45dc-854d-8c30a52fa9554
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDd8d44758-d9a9-45dc-854d-8c30a52fa9554
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDd8d44758-d9a9-45dc-854d-8c30a52fa9554
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDd8d44758-d9a9-45dc-854d-8c30a52fa9554
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYd8d44758-d9a9-45dc-854d-8c30a52fa9554
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYd8d44758-d9a9-45dc-854d-8c30a52fa9554
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSYd8d44758-d9a9-45dc-854d-8c30a52fa9554
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN8a9875f5-2889-5149-e053-2995a90a46c03
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN86be8920-2f35-fbc3-e053-2991aa0a00153
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD86be8920-2f35-fbc3-e053-2991aa0a00153
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD8a9875f5-2889-5149-e053-2995a90a46c03
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY86be8920-2f35-fbc3-e053-2991aa0a00153
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY8a9875f5-2889-5149-e053-2995a90a46c03
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN8e48b57b-74fc-10f6-e053-2995a90a04ef2
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN8e4795c8-97d0-6a72-e053-2a95a90a196a2
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNa0c12cc7-652f-2d8b-e053-2995a90a38ea2
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN8de12c9f-eb17-aa26-e053-2a95a90a1b9c2
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN8de1cc02-1643-4a3b-e053-2a95a90a2fb12
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD8e48b57b-74fc-10f6-e053-2995a90a04ef2
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD8e4795c8-97d0-6a72-e053-2a95a90a196a2
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD8de1cc02-1643-4a3b-e053-2a95a90a2fb12
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDa0c12cc7-652f-2d8b-e053-2995a90a38ea2
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD8de12c9f-eb17-aa26-e053-2a95a90a1b9c2
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY8de12c9f-eb17-aa26-e053-2a95a90a1b9c2
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYa0c12cc7-652f-2d8b-e053-2995a90a38ea2
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY8e48b57b-74fc-10f6-e053-2995a90a04ef2
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY8e4795c8-97d0-6a72-e053-2a95a90a196a2
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY8de1cc02-1643-4a3b-e053-2a95a90a2fb12
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN915bb8df-8f50-454b-98e4-4cb8264071c91
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN86325900-d617-f02b-e053-2991aa0a8e991
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD915bb8df-8f50-454b-98e4-4cb8264071c91
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD86325900-d617-f02b-e053-2991aa0a8e991
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY915bb8df-8f50-454b-98e4-4cb8264071c91
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY86325900-d617-f02b-e053-2991aa0a8e991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-019-0113107001901100 TABLET in 1 BOTTLE (13107-019-01) 100 tablet2012-04-110000-00-00NoNoCurrent
13107-019-0513107001905500 TABLET in 1 BOTTLE (13107-019-05) 500 tablet2012-04-110000-00-00NoNoCurrent
13107-019-301310700193030 TABLET in 1 BOTTLE (13107-019-30) 30 tablet2012-04-110000-00-00NoNoCurrent
13107-019-99131070019991000 TABLET in 1 BOTTLE (13107-019-99) 1000 tablet2012-04-110000-00-00NoNoCurrent