FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
53746-110
11-digit product format
537460110
Labeler code
53746
Product ID
53746-110_0ff1e133-cee6-44cd-a7ce-ad9092389089
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA040746
Marketing category
ANDA
Marketing start
2010-02-18
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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53746-110-012021-02-03C16284748780-1ba0f9c33-48d5-a910-e053-dadaa90a0b85Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (10 mg/325 mg)
53746-110-052021-02-03C16284748780-1ba0f9c33-48d5-a910-e053-dadaa90a0b85Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (10 mg/325 mg)
53746-110-102021-02-03C16284748780-1ba0f9c33-48d5-a910-e053-dadaa90a0b85Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (10 mg/325 mg)
53746-110-012021-01-29C16284748780-1ba0f9c33-48d5-a910-e053-dadaa90a0b85Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (10 mg/325 mg)
53746-110-052021-01-29C16284748780-1ba0f9c33-48d5-a910-e053-dadaa90a0b85Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (10 mg/325 mg)
53746-110-102021-01-29C16284748780-1ba0f9c33-48d5-a910-e053-dadaa90a0b85Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII (10 mg/325 mg)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-110-01Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLETABLET10050
53746-110-05Hydrocodone Bitartrate and Acetaminophen500 in 1 BOTTLETABLET50050
53746-110-10Hydrocodone Bitartrate and Acetaminophen1000 in 1 BOTTLETABLET100050

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-110-01EA - Each53746-110022a9849-0646-4c7e-91bb-bdd537bdf12312012-07-24
53746-110-05EA - Each53746-11021a67612-457b-4ddd-a8fd-64f109776ef212012-07-24
53746-110-10EA - Each53746-1100d596bd2-eda8-4d23-bedd-0e578ced77a712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]18
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]18
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]18
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]18
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]18
CROSPOVIDONE (15 MPA.S AT 5%)INACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]18
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]18
POVIDONESINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]18
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]18
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]18
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]18
.GAMMA.-AMINOBUTYRIC ACIDACTIVE INGREDIENT2ACZ6IPC6ITHERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTHERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKTHERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
.GAMMA.-AMINOBUTYRIC ACIDACTIVE MOIETY2ACZ6IPC6ITHERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTHERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7THERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTHERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
GELATININACTIVE INGREDIENT2G86QN327LTHERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30THERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DTHERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4THERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REDPHARM DRUG INC.]4
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA, INC.]4
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REDPHARM DRUG INC.]4
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA, INC.]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REDPHARM DRUG INC.]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA, INC.]4
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REDPHARM DRUG INC.]4
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REDPHARM DRUG INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REDPHARM DRUG INC.]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REDPHARM DRUG INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA, INC.]4
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP]3
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE TABLET [DIRECT RX]3
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP]3
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE TABLET [DIRECT RX]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE TABLET [DIRECT RX]3
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP]3
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE TABLET [DIRECT RX]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE TABLET [DIRECT RX]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE TABLET [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE TABLET [DIRECT RX]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE TABLET [DIRECT RX]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE TABLET [DIRECT RX]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE TABLET [DIRECT RX]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE TABLET [DIRECT RX]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP]3
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]2
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP.]2
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP.]2
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP.]2
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP.]2
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]2
CrospovidoneINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]2
PovidonesINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]2
Starch, CornINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]2
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]2
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]1
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]1
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-110HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]47Current NDC, Legacy NDC, 3 package rows20240215_e0cefc7b-e81c-4e15-89a0-fe71dc94338b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNe0cefc7b-e81c-4e15-89a0-fe71dc94338b50
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDe0cefc7b-e81c-4e15-89a0-fe71dc94338b50
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYe0cefc7b-e81c-4e15-89a0-fe71dc94338b50
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN8965ee35-89b9-4c11-9cee-fdcbe886cf6e14
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD8965ee35-89b9-4c11-9cee-fdcbe886cf6e14
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY8965ee35-89b9-4c11-9cee-fdcbe886cf6e14
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN1ac64001-75dd-4fba-9a89-9969364e5c9a9
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD1ac64001-75dd-4fba-9a89-9969364e5c9a9
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY1ac64001-75dd-4fba-9a89-9969364e5c9a9
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN5174bd9a-b777-a6e3-f72f-c16082ee67d38
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN5174bd9a-b777-a6e3-f72f-c16082ee67d38
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD5174bd9a-b777-a6e3-f72f-c16082ee67d38
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD5174bd9a-b777-a6e3-f72f-c16082ee67d38
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY5174bd9a-b777-a6e3-f72f-c16082ee67d38
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY5174bd9a-b777-a6e3-f72f-c16082ee67d38
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNbab189ed-ff83-453c-a243-7ff052b2e4915
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDbab189ed-ff83-453c-a243-7ff052b2e4915
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYbab189ed-ff83-453c-a243-7ff052b2e4915
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNe2f2b9e3-2cb6-4330-8446-5c01ebe1fa194
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNfcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e4
857107HYDROcodone bitartrate 10 MG / acetaminophen 500 MG Oral TabletPSNfcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e4
857383HYDROcodone bitartrate 10 MG / acetaminophen 650 MG Oral TabletPSNfcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e4
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDfcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e4
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDe2f2b9e3-2cb6-4330-8446-5c01ebe1fa194
857107acetaminophen 500 MG / hydrocodone bitartrate 10 MG Oral TabletSCDfcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e4
857383acetaminophen 650 MG / hydrocodone bitartrate 10 MG Oral TabletSCDfcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e4
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYe2f2b9e3-2cb6-4330-8446-5c01ebe1fa194
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYfcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e4
857107APAP 500 MG / hydrocodone bitartrate 10 MG Oral TabletSYfcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e4
857383APAP 650 MG / hydrocodone bitartrate 10 MG Oral TabletSYfcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e4
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNf6d5fe9a-032f-4cea-8e75-0849878a36bc2
856903HYDROcodone bitartrate 5 MG / acetaminophen 500 MG Oral TabletPSNf6d5fe9a-032f-4cea-8e75-0849878a36bc2
857118HYDROcodone bitartrate 7.5 MG / acetaminophen 500 MG Oral TabletPSNf6d5fe9a-032f-4cea-8e75-0849878a36bc2
833036HYDROcodone bitartrate 7.5 MG / acetaminophen 750 MG Oral TabletPSNf6d5fe9a-032f-4cea-8e75-0849878a36bc2
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDf6d5fe9a-032f-4cea-8e75-0849878a36bc2
856903acetaminophen 500 MG / hydrocodone bitartrate 5 MG Oral TabletSCDf6d5fe9a-032f-4cea-8e75-0849878a36bc2
857118acetaminophen 500 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDf6d5fe9a-032f-4cea-8e75-0849878a36bc2
833036acetaminophen 750 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDf6d5fe9a-032f-4cea-8e75-0849878a36bc2
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYf6d5fe9a-032f-4cea-8e75-0849878a36bc2
856903APAP 500 MG / hydrocodone bitartrate 5 MG Oral TabletSYf6d5fe9a-032f-4cea-8e75-0849878a36bc2
857118APAP 500 MG / hydrocodone bitartrate 7.5 MG Oral TabletSYf6d5fe9a-032f-4cea-8e75-0849878a36bc2
833036APAP 750 MG / hydrocodone bitartrate 7.5 MG Oral TabletSYf6d5fe9a-032f-4cea-8e75-0849878a36bc2
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN45b2deca-b5d4-4c5d-aa6a-e7063aaa44fb1
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN2a53c7e4-c518-4714-e054-00144ff88e881
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD45b2deca-b5d4-4c5d-aa6a-e7063aaa44fb1
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD2a53c7e4-c518-4714-e054-00144ff88e881
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY2a53c7e4-c518-4714-e054-00144ff88e881
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY45b2deca-b5d4-4c5d-aa6a-e7063aaa44fb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-110-0153746011001100 TABLET in 1 BOTTLE (53746-110-01) 100 tablet2010-02-180000-00-00NoNoCurrent
53746-110-0553746011005500 TABLET in 1 BOTTLE (53746-110-05) 500 tablet2010-02-180000-00-00NoNoCurrent
53746-110-10537460110101000 TABLET in 1 BOTTLE (53746-110-10) 1000 tablet2010-02-180000-00-00NoNoCurrent