FDA.reportPublic FDA data

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC
0406-0125
11-digit product format
004060125
Labeler code
0406
Product ID
0406-0125_748bcfb4-7b4c-420c-a9c8-c93fd481f3d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA040400
Marketing category
ANDA
Marketing start
2000-07-26
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
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
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
a5244f9c-cd67-0e27-d63b-65fd7e584400Product name220170504
b654f2d9-ebeb-451d-96ee-22f583344623Product name120170424
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
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
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0406-0125-01HYDROCODONE BITARTRATE AND ACETAMINOPHEN100 in 1 BOTTLETABLET10056
0406-0125-05HYDROCODONE BITARTRATE AND ACETAMINOPHEN500 in 1 BOTTLETABLET50056
0406-0125-10HYDROCODONE BITARTRATE AND ACETAMINOPHEN1000 in 1 BOTTLETABLET100056
0406-0125-12HYDROCODONE BITARTRATE AND ACETAMINOPHEN120 in 1 BOTTLETABLET12056
0406-0125-20HYDROCODONE BITARTRATE AND ACETAMINOPHEN20 in 1 BOTTLETABLET2056
0406-0125-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN1 in 1 BLISTER PACKTABLET156
0406-0125-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN30 in 1 BOTTLETABLET3056
0406-0125-60HYDROCODONE BITARTRATE AND ACETAMINOPHEN60 in 1 BOTTLETABLET6056
0406-0125-62HYDROCODONE BITARTRATE AND ACETAMINOPHEN100 in 1 BLISTER PACKTABLET10056
0406-0125-90HYDROCODONE BITARTRATE AND ACETAMINOPHEN90 in 1 BOTTLETABLET9056

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-0125-01EA - Each0406-0125c40d613d-0a4c-4582-8177-9a2994a70b2112014-10-03
0406-0125-05EA - Each0406-01255315705c-938c-463d-a86e-be14f53877bb12014-10-03
0406-0125-10EA - Each0406-01257ea80bf4-3f7f-487b-b6db-40ba7136c79712016-09-02
0406-0125-12EA - Each0406-012509775b52-9b6b-403d-971b-3712e2471c8812017-08-11
0406-0125-23EA - Each0406-01251b939352-51b2-43a0-9616-1297325227eb12014-10-03
0406-0125-60EA - Each0406-0125b84427d0-1055-4da7-936f-ebe058d8b3fe12018-08-13
0406-0125-62EA - Each0406-01256b63f17d-de3d-44d2-a72c-868a266daa2c12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MALLINCKRODT, INC.]29
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MALLINCKRODT, INC.]29
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MALLINCKRODT, INC.]29
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MALLINCKRODT, INC.]29
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MALLINCKRODT, INC.]29
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MALLINCKRODT, INC.]29
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MALLINCKRODT, INC.]29
POVIDONESINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MALLINCKRODT, INC.]29
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MALLINCKRODT, INC.]29
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MALLINCKRODT, INC.]29
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MALLINCKRODT, INC.]29

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-0125HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [SPECGX LLC]54Current NDC, Legacy NDC, 10 package rows20240627_73c1059b-0c7d-42ef-9827-f018858fc447.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN73c1059b-0c7d-42ef-9827-f018858fc44756
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN73c1059b-0c7d-42ef-9827-f018858fc44756
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN73c1059b-0c7d-42ef-9827-f018858fc44756
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD73c1059b-0c7d-42ef-9827-f018858fc44756
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD73c1059b-0c7d-42ef-9827-f018858fc44756
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD73c1059b-0c7d-42ef-9827-f018858fc44756
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY73c1059b-0c7d-42ef-9827-f018858fc44756
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY73c1059b-0c7d-42ef-9827-f018858fc44756
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY73c1059b-0c7d-42ef-9827-f018858fc44756
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN3d342071-7fdd-d899-e063-6294a90ae7824
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD3d342071-7fdd-d899-e063-6294a90ae7824
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY3d342071-7fdd-d899-e063-6294a90ae7824
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN57ea4bd2-d4bd-4394-e053-2991aa0a2bb43
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNe7d36246-9c80-49b6-ad4b-e38c3fd6d0683
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNfc4e3a24-4f29-c138-e053-6294a90a3d943
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD57ea4bd2-d4bd-4394-e053-2991aa0a2bb43
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDe7d36246-9c80-49b6-ad4b-e38c3fd6d0683
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDfc4e3a24-4f29-c138-e053-6294a90a3d943
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY57ea4bd2-d4bd-4394-e053-2991aa0a2bb43
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYe7d36246-9c80-49b6-ad4b-e38c3fd6d0683
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYfc4e3a24-4f29-c138-e053-6294a90a3d943
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN62dd3c7a-4150-44a2-b05b-bc31308f22001
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD62dd3c7a-4150-44a2-b05b-bc31308f22001
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY62dd3c7a-4150-44a2-b05b-bc31308f22001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-0125-0100406012501100 TABLET in 1 BOTTLE (0406-0125-01) 100 tablet2000-07-260000-00-00NoNoCurrent
0406-0125-0500406012505500 TABLET in 1 BOTTLE (0406-0125-05) 500 tablet2000-07-260000-00-00NoNoCurrent
0406-0125-10004060125101000 TABLET in 1 BOTTLE (0406-0125-10) 1000 tablet2000-07-260000-00-00NoNoCurrent
0406-0125-1200406012512120 TABLET in 1 BOTTLE (0406-0125-12) 120 tablet2000-07-260000-00-00NoNoCurrent
0406-0125-200040601252020 TABLET in 1 BOTTLE (0406-0125-20) 20 tablet2000-07-260000-00-00NoNoCurrent
0406-0125-23004060125231 TABLET in 1 BLISTER PACK (0406-0125-23) 1 tablet2000-07-260000-00-00NoNoCurrent
0406-0125-300040601253030 TABLET in 1 BOTTLE (0406-0125-30) 30 tablet2000-07-260000-00-00NoNoCurrent
0406-0125-600040601256060 TABLET in 1 BOTTLE (0406-0125-60) 60 tablet2000-07-260000-00-00NoNoCurrent
0406-0125-6200406012562100 TABLET in 1 BLISTER PACK (0406-0125-62) 100 tablet2000-07-260000-00-00NoNoCurrent
0406-0125-900040601259090 TABLET in 1 BOTTLE (0406-0125-90) 90 tablet2000-07-260000-00-00NoNoCurrent