FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
65162-115
11-digit product format
651620115
Labeler code
65162
Product ID
65162-115_1b44ad7b-ee24-499c-9814-24a95779a97f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA040746
Marketing category
ANDA
Marketing start
2016-06-30
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 7.5 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 BITARTRATE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, NO70W886KK
Rxcui857005

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
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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
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
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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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
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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
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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
65162-115-032024-02-13C16284748780-11030e365-172c-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (7.5 mg/325 mg)
65162-115-102024-02-13C16284748780-11030e365-172c-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (7.5 mg/325 mg)
65162-115-112024-02-13C16284748780-11030e365-172c-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (7.5 mg/325 mg)
65162-115-502024-02-13C16284748780-11030e365-172c-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (7.5 mg/325 mg)
65162-115-032024-01-30C16284748780-11030e365-172c-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (7.5 mg/325 mg)
65162-115-102024-01-30C16284748780-11030e365-172c-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (7.5 mg/325 mg)
65162-115-112024-01-30C16284748780-11030e365-172c-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (7.5 mg/325 mg)
65162-115-502024-01-30C16284748780-11030e365-172c-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (7.5 mg/325 mg)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-115-03Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET3039
65162-115-10Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLETABLET10039
65162-115-11Hydrocodone Bitartrate and Acetaminophen1000 in 1 BOTTLETABLET100039
65162-115-50Hydrocodone Bitartrate and Acetaminophen500 in 1 BOTTLETABLET50039

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-115HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS LLC]37Current NDC, Legacy NDC, 4 package rows20240214_e23d135c-7aea-405a-804e-5c4f82179e96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSNe23d135c-7aea-405a-804e-5c4f82179e9639
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDe23d135c-7aea-405a-804e-5c4f82179e9639
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSYe23d135c-7aea-405a-804e-5c4f82179e9639
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN504b4763-a992-2760-e054-00144ff8d46c7
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD504b4763-a992-2760-e054-00144ff8d46c7
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY504b4763-a992-2760-e054-00144ff8d46c7
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN678f3d54-3b62-c9e8-2ff3-a2a6bd9ecfc36
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD678f3d54-3b62-c9e8-2ff3-a2a6bd9ecfc36
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY678f3d54-3b62-c9e8-2ff3-a2a6bd9ecfc36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-115-036516201150330 TABLET in 1 BOTTLE (65162-115-03) 30 tablet2016-06-300000-00-00NoNoCurrent
65162-115-1065162011510100 TABLET in 1 BOTTLE (65162-115-10) 100 tablet2016-06-300000-00-00NoNoCurrent
65162-115-11651620115111000 TABLET in 1 BOTTLE (65162-115-11) 1000 tablet2016-06-300000-00-00NoNoCurrent
65162-115-5065162011550500 TABLET in 1 BOTTLE (65162-115-50) 500 tablet2016-06-300000-00-00NoNoCurrent