FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
71930-021
11-digit product format
719300021
Labeler code
71930
Product ID
71930-021_a9e9366b-97c9-4d86-962f-b3f8e3338fa9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Eywa Pharma Inc
Application
ANDA210211
Marketing category
ANDA
Marketing start
2018-07-13
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
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
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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
377068df-225f-7318-a910-a1987cdfa361Product name320170608
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b654f2d9-ebeb-451d-96ee-22f583344623Product name120170424
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
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e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
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
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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
71930-021-12Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLETABLET1008
71930-021-13Hydrocodone Bitartrate and Acetaminophen1000 in 1 BOTTLETABLET10008
71930-021-52Hydrocodone Bitartrate and Acetaminophen500 in 1 BOTTLETABLET5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71930-021-12EA - Each71930-02100111bd1-72e7-4954-b6ae-f9dd5f55ec1d12018-10-11
71930-021-13EA - Each71930-0212737b85e-7618-41ce-8fd6-f8ad45f31d0e12022-12-07
71930-021-52EA - Each71930-021b4bb2fb2-f1e1-49d8-9688-ca5df22b14e612018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71930-021HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [EYWA PHARMA INC]7Current NDC, Legacy NDC, 3 package rows20240829_fcd2b59e-8087-475e-9e6b-911bd846ea96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN09db348f-8396-41b2-b639-608dcfdbccf4105
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD09db348f-8396-41b2-b639-608dcfdbccf4105
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY09db348f-8396-41b2-b639-608dcfdbccf4105
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN42a74abc-bdc7-4ea3-a185-029340111730103
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD42a74abc-bdc7-4ea3-a185-029340111730103
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY42a74abc-bdc7-4ea3-a185-029340111730103
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNc534f784-0e21-4891-8f7e-2dc327b267f1102
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDc534f784-0e21-4891-8f7e-2dc327b267f1102
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYc534f784-0e21-4891-8f7e-2dc327b267f1102
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNfcd2b59e-8087-475e-9e6b-911bd846ea968
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN9d76aaf6-e3e0-4ec1-9f20-3d5ab88de6308
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN9d76aaf6-e3e0-4ec1-9f20-3d5ab88de6308
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNfcd2b59e-8087-475e-9e6b-911bd846ea968
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSNfcd2b59e-8087-475e-9e6b-911bd846ea968
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN9d76aaf6-e3e0-4ec1-9f20-3d5ab88de6308
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD9d76aaf6-e3e0-4ec1-9f20-3d5ab88de6308
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDfcd2b59e-8087-475e-9e6b-911bd846ea968
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDfcd2b59e-8087-475e-9e6b-911bd846ea968
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD9d76aaf6-e3e0-4ec1-9f20-3d5ab88de6308
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDfcd2b59e-8087-475e-9e6b-911bd846ea968
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD9d76aaf6-e3e0-4ec1-9f20-3d5ab88de6308
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYfcd2b59e-8087-475e-9e6b-911bd846ea968
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY9d76aaf6-e3e0-4ec1-9f20-3d5ab88de6308
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYfcd2b59e-8087-475e-9e6b-911bd846ea968
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY9d76aaf6-e3e0-4ec1-9f20-3d5ab88de6308
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY9d76aaf6-e3e0-4ec1-9f20-3d5ab88de6308
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSYfcd2b59e-8087-475e-9e6b-911bd846ea968
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN446e9f78-4034-5bb4-e063-6394a90ac7392
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN66e184cd-fa32-431f-b843-9c4bea12593b2
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN66e184cd-fa32-431f-b843-9c4bea12593b2
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN66e184cd-fa32-431f-b843-9c4bea12593b2
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD66e184cd-fa32-431f-b843-9c4bea12593b2
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD446e9f78-4034-5bb4-e063-6394a90ac7392
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD66e184cd-fa32-431f-b843-9c4bea12593b2
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD66e184cd-fa32-431f-b843-9c4bea12593b2
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY446e9f78-4034-5bb4-e063-6394a90ac7392
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY66e184cd-fa32-431f-b843-9c4bea12593b2
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY66e184cd-fa32-431f-b843-9c4bea12593b2
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY66e184cd-fa32-431f-b843-9c4bea12593b2
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNe181d8cf-3722-3eb4-e053-2995a90ad35d1
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNd696662b-e4a4-3474-e053-2995a90a93891
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDe181d8cf-3722-3eb4-e053-2995a90ad35d1
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDd696662b-e4a4-3474-e053-2995a90a93891
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYe181d8cf-3722-3eb4-e053-2995a90ad35d1
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYd696662b-e4a4-3474-e053-2995a90a93891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71930-021-1271930002112100 TABLET in 1 BOTTLE (71930-021-12) 100 tablet2018-07-130000-00-00NoNoCurrent
71930-021-13719300021131000 TABLET in 1 BOTTLE (71930-021-13) 1000 tablet2022-10-060000-00-00NoNoCurrent
71930-021-5271930002152500 TABLET in 1 BOTTLE (71930-021-52) 500 tablet2018-07-130000-00-00NoNoCurrent