FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
13107-021
11-digit product format
131070021
Labeler code
13107
Product ID
13107-021_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; 10 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 BITARTRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, NO70W886KK
Rxcui856999, 857002, 857005

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
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11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
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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
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20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
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aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
7855f8e3-562e-4273-8b79-0059c07a71f7Product name120170901
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
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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
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cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13107-021-01Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLETABLET10019
13107-021-05Hydrocodone Bitartrate and Acetaminophen500 in 1 BOTTLETABLET50019
13107-021-30Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET3019
13107-021-99Hydrocodone Bitartrate and Acetaminophen1000 in 1 BOTTLETABLET100019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-021-01EA - Each13107-0211b6b3e65-49d1-49dd-8cd7-eea81efd1a5212013-02-13
13107-021-05EA - Each13107-021de7a55d6-c821-4b5f-a964-3e64278838af12013-02-13
13107-021-99EA - Each13107-021e27cb035-eae0-457c-b17c-c04227ad61c312013-02-13

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-021HYDROCODONE 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 TabletPSNddfe71cc-27bf-4807-b62f-e6cf982e2dfd102
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDddfe71cc-27bf-4807-b62f-e6cf982e2dfd102
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYddfe71cc-27bf-4807-b62f-e6cf982e2dfd102
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
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN199d4915-cb3b-48f3-835d-a45d04a5c9406
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD199d4915-cb3b-48f3-835d-a45d04a5c9406
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY199d4915-cb3b-48f3-835d-a45d04a5c9406
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN88c031ee-3d3d-4e8a-b69b-d18db612a9f35
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD88c031ee-3d3d-4e8a-b69b-d18db612a9f35
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY88c031ee-3d3d-4e8a-b69b-d18db612a9f35
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
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN8c2a7a68-5a84-c909-e053-2995a90ad5b63
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN90a1f7e4-b645-1118-e053-2a95a90ae9123
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN8b132cf3-c138-59ae-e053-2995a90a98a23
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD8c2a7a68-5a84-c909-e053-2995a90ad5b63
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD90a1f7e4-b645-1118-e053-2a95a90ae9123
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD8b132cf3-c138-59ae-e053-2995a90a98a23
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY8c2a7a68-5a84-c909-e053-2995a90ad5b63
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY90a1f7e4-b645-1118-e053-2a95a90ae9123
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY8b132cf3-c138-59ae-e053-2995a90a98a23
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNeba5c518-ed6b-4ada-847f-640d000cb1ca2
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDeba5c518-ed6b-4ada-847f-640d000cb1ca2
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYeba5c518-ed6b-4ada-847f-640d000cb1ca2
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN90a1e58d-8d84-10e9-e053-2995a90a74491
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN90a0f135-c49a-20b3-e053-2995a90a33af1
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD90a1e58d-8d84-10e9-e053-2995a90a74491
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD90a0f135-c49a-20b3-e053-2995a90a33af1
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY90a1e58d-8d84-10e9-e053-2995a90a74491
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY90a0f135-c49a-20b3-e053-2995a90a33af1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-021-0113107002101100 TABLET in 1 BOTTLE (13107-021-01) 100 tablet2012-04-110000-00-00NoNoCurrent
13107-021-0513107002105500 TABLET in 1 BOTTLE (13107-021-05) 500 tablet2012-04-110000-00-00NoNoCurrent
13107-021-301310700213030 TABLET in 1 BOTTLE (13107-021-30) 30 tablet2012-04-110000-00-00NoNoCurrent
13107-021-99131070021991000 TABLET in 1 BOTTLE (13107-021-99) 1000 tablet2012-04-110000-00-00NoNoCurrent