FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
42858-203
11-digit product format
428580203
Labeler code
42858
Product ID
42858-203_0020dbf9-540c-4f0e-87e9-77b39195004a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Rhodes Pharmaceuticals L.P.
Application
ANDA202991
Marketing category
ANDA
Marketing start
2016-04-12
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocodone Bitartrate and Acetaminophen
Listing expiration
2027-12-31

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
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11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
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
377068df-225f-7318-a910-a1987cdfa361Product name320170608
a5244f9c-cd67-0e27-d63b-65fd7e584400Product name220170504
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
42858-203-01Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLETABLET10019
42858-203-10Hydrocodone Bitartrate and Acetaminophen100 in 1 BOX, UNIT-DOSETABLET10019
42858-203-10Hydrocodone Bitartrate and Acetaminophen1 in 1 BLISTER PACKTABLET119
42858-203-50Hydrocodone Bitartrate and Acetaminophen500 in 1 BOTTLETABLET50019
42858-203-90Hydrocodone Bitartrate and Acetaminophen1000 in 1 BOTTLETABLET100019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42858-203-01EA - Each42858-2037a3b020e-a18d-451c-b695-1e126d849e8c12016-05-16
42858-203-50EA - Each42858-20303b902ec-f981-47ab-8120-46790d7862ab12016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42858-203HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RHODES PHARMACEUTICALS L.P.]16Current NDC, Legacy NDC, 5 package rows20240719_1f9c1adc-f84f-43de-af5c-d93703aba7f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN878c004c-1e92-4400-95f5-e79cf9ba6844106
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN3d431951-eb0f-45ac-a6ba-d99929bdcaaf106
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD878c004c-1e92-4400-95f5-e79cf9ba6844106
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD3d431951-eb0f-45ac-a6ba-d99929bdcaaf106
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY878c004c-1e92-4400-95f5-e79cf9ba6844106
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY3d431951-eb0f-45ac-a6ba-d99929bdcaaf106
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNe83d90f9-513b-47c2-ae2a-748ce775ef5d103
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN418ea599-55e0-4d57-a4b1-16568e30f6f7103
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN29491adb-d95d-4f68-ac01-61bad73e08fc103
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDe83d90f9-513b-47c2-ae2a-748ce775ef5d103
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD418ea599-55e0-4d57-a4b1-16568e30f6f7103
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD29491adb-d95d-4f68-ac01-61bad73e08fc103
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY29491adb-d95d-4f68-ac01-61bad73e08fc103
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYe83d90f9-513b-47c2-ae2a-748ce775ef5d103
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY418ea599-55e0-4d57-a4b1-16568e30f6f7103
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN1f9c1adc-f84f-43de-af5c-d93703aba7f820
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN1f9c1adc-f84f-43de-af5c-d93703aba7f820
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN1f9c1adc-f84f-43de-af5c-d93703aba7f820
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD1f9c1adc-f84f-43de-af5c-d93703aba7f820
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD1f9c1adc-f84f-43de-af5c-d93703aba7f820
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD1f9c1adc-f84f-43de-af5c-d93703aba7f820
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY1f9c1adc-f84f-43de-af5c-d93703aba7f820
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY1f9c1adc-f84f-43de-af5c-d93703aba7f820
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY1f9c1adc-f84f-43de-af5c-d93703aba7f820
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN503457f0-7e83-56c8-e054-00144ff88e884
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD503457f0-7e83-56c8-e054-00144ff88e884
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY503457f0-7e83-56c8-e054-00144ff88e884
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN5c00f98f-dcab-4bdb-901e-02eb873dea311
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD5c00f98f-dcab-4bdb-901e-02eb873dea311
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY5c00f98f-dcab-4bdb-901e-02eb873dea311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42858-203-0142858020301100 TABLET in 1 BOTTLE (42858-203-01) 100 tablet2016-04-120000-00-00NoNoCurrent
42858-203-1042858020310100 BLISTER PACK in 1 BOX, UNIT-DOSE (42858-203-10) / 1 TABLET in 1 BLISTER PACK100 blister pack2016-04-120000-00-00NoNoCurrent
42858-203-5042858020350500 TABLET in 1 BOTTLE (42858-203-50) 500 tablet2016-04-120000-00-00NoNoCurrent
42858-203-90428580203901000 TABLET in 1 BOTTLE (42858-203-90) 1000 tablet2016-04-120000-00-00NoNoCurrent