FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
42858-202
11-digit product format
428580202
Labeler code
42858
Product ID
42858-202_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; 7.5 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 BITARTRATE7.5 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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7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
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
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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
42858-202-01Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLETABLET10019
42858-202-10Hydrocodone Bitartrate and Acetaminophen1 in 1 BLISTER PACKTABLET119
42858-202-10Hydrocodone Bitartrate and Acetaminophen100 in 1 BOX, UNIT-DOSETABLET10019
42858-202-50Hydrocodone Bitartrate and Acetaminophen500 in 1 BOTTLETABLET50019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42858-202-01EA - Each42858-2023204e0c3-154a-4351-8cb6-8da05f44300312016-05-16
42858-202-50EA - Each42858-202eba9c3aa-fcc1-4379-bc92-94b4c646544712024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42858-202HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RHODES PHARMACEUTICALS L.P.]16Current NDC, Legacy NDC, 4 package rows20240719_1f9c1adc-f84f-43de-af5c-d93703aba7f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN8ad0df84-e3f6-4c1d-b791-c8467eb984aa104
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD8ad0df84-e3f6-4c1d-b791-c8467eb984aa104
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY8ad0df84-e3f6-4c1d-b791-c8467eb984aa104
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSNa2e33ea3-941f-4810-b008-abbb109730a9103
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDa2e33ea3-941f-4810-b008-abbb109730a9103
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSYa2e33ea3-941f-4810-b008-abbb109730a9103
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
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN0cc8836b-f0af-42e0-bd77-53fd1dd1aca711
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD0cc8836b-f0af-42e0-bd77-53fd1dd1aca711
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY0cc8836b-f0af-42e0-bd77-53fd1dd1aca711
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN5023c851-d257-48f1-e054-00144ff88e884
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD5023c851-d257-48f1-e054-00144ff88e884
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY5023c851-d257-48f1-e054-00144ff88e884
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN84bbdc7b-70cd-4225-9b20-d6d21796775f3
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD84bbdc7b-70cd-4225-9b20-d6d21796775f3
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY84bbdc7b-70cd-4225-9b20-d6d21796775f3
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN23dde6b8-3655-49ee-ac2c-28f80cf6b3c21
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD23dde6b8-3655-49ee-ac2c-28f80cf6b3c21
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY23dde6b8-3655-49ee-ac2c-28f80cf6b3c21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42858-202-0142858020201100 TABLET in 1 BOTTLE (42858-202-01) 100 tablet2016-04-120000-00-00NoNoCurrent
42858-202-1042858020210100 BLISTER PACK in 1 BOX, UNIT-DOSE (42858-202-10) / 1 TABLET in 1 BLISTER PACK100 blister pack2016-04-120000-00-00NoNoCurrent
42858-202-5042858020250500 in 1 BOTTLEHistorical