FDA.reportPublic FDA data

Hysingla ER

Product NDC
59011-271
11-digit product format
590110271
Labeler code
59011
Product ID
59011-271_a4f435c1-f825-4252-b9e2-d3a04a674ff3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocodone bitartrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Knoa Pharma LLC
Application
NDA206627
Marketing category
NDA
Marketing start
2015-01-15
Substance
HYDROCODONE BITARTRATE
Active strength
20 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
Hysingla ER
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCODONE BITARTRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNO70W886KK
Rxcui1595730, 1595736, 1595740, 1595742, 1595746, 1595748, 1595752, 1595754, 1595758, 1595760, 1595764, 1595766, 1595770, 1595772

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
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
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59011-271-60Hysingla ER60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE6016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59011-271-60EA - Each59011-271e8844dab-fa58-4fc4-9290-fa1d911e9a1512015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]3
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]3
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KHYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]3
COCHINEALINACTIVE INGREDIENTTZ8Z31B35MHYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTHYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PHYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]3
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PHYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AHYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]3
TALCINACTIVE INGREDIENT7SEV7J4R1UHYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59011-271HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [PURDUE PHARMA LP]13Current NDC, Legacy NDC, 1 package rows20240612_b7d23ac2-e776-9f62-3290-c64c2d6eb353.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1595764HYDROcodone bitartrate 100 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSNb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595770HYDROcodone bitartrate 120 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSNb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595730HYDROcodone bitartrate 20 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSNb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595740HYDROcodone bitartrate 30 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSNb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595746HYDROcodone bitartrate 40 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSNb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595752HYDROcodone bitartrate 60 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSNb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595758HYDROcodone bitartrate 80 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSNb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595766Hysingla ER 100 MG 24HR Extended Release Oral TabletPSNb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595772Hysingla ER 120 MG 24HR Extended Release Oral TabletPSNb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595736Hysingla ER 20 MG 24HR Extended Release Oral TabletPSNb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595742Hysingla ER 30 MG 24HR Extended Release Oral TabletPSNb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595748Hysingla ER 40 MG 24HR Extended Release Oral TabletPSNb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595754Hysingla ER 60 MG 24HR Extended Release Oral TabletPSNb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595760Hysingla ER 80 MG 24HR Extended Release Oral TabletPSNb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595766Abuse-Deterrent 24 HR hydrocodone bitartrate 100 MG Extended Release Oral Tablet [Hysingla]SBDb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595772Abuse-Deterrent 24 HR hydrocodone bitartrate 120 MG Extended Release Oral Tablet [Hysingla]SBDb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595736Abuse-Deterrent 24 HR hydrocodone bitartrate 20 MG Extended Release Oral Tablet [Hysingla]SBDb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595742Abuse-Deterrent 24 HR hydrocodone bitartrate 30 MG Extended Release Oral Tablet [Hysingla]SBDb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595748Abuse-Deterrent 24 HR hydrocodone bitartrate 40 MG Extended Release Oral Tablet [Hysingla]SBDb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595754Abuse-Deterrent 24 HR hydrocodone bitartrate 60 MG Extended Release Oral Tablet [Hysingla]SBDb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595760Abuse-Deterrent 24 HR hydrocodone bitartrate 80 MG Extended Release Oral Tablet [Hysingla]SBDb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595764Abuse-Deterrent 24 HR hydrocodone bitartrate 100 MG Extended Release Oral TabletSCDb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595770Abuse-Deterrent 24 HR hydrocodone bitartrate 120 MG Extended Release Oral TabletSCDb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595730Abuse-Deterrent 24 HR hydrocodone bitartrate 20 MG Extended Release Oral TabletSCDb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595740Abuse-Deterrent 24 HR hydrocodone bitartrate 30 MG Extended Release Oral TabletSCDb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595746Abuse-Deterrent 24 HR hydrocodone bitartrate 40 MG Extended Release Oral TabletSCDb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595752Abuse-Deterrent 24 HR hydrocodone bitartrate 60 MG Extended Release Oral TabletSCDb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595758Abuse-Deterrent 24 HR hydrocodone bitartrate 80 MG Extended Release Oral TabletSCDb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595764hydrocodone bitartrate 100 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSYb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595770hydrocodone bitartrate 120 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSYb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595730hydrocodone bitartrate 20 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSYb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595740hydrocodone bitartrate 30 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSYb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595746hydrocodone bitartrate 40 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSYb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595752hydrocodone bitartrate 60 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSYb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595758hydrocodone bitartrate 80 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSYb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595766Hysingla ER 100 MG 24 HR Extended Release Oral TabletSYb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595772Hysingla ER 120 MG 24 HR Extended Release Oral TabletSYb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595736Hysingla ER 20 MG 24 HR Extended Release Oral TabletSYb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595742Hysingla ER 30 MG 24 HR Extended Release Oral TabletSYb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595748Hysingla ER 40 MG 24 HR Extended Release Oral TabletSYb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595754Hysingla ER 60 MG 24 HR Extended Release Oral TabletSYb7d23ac2-e776-9f62-3290-c64c2d6eb35316
1595760Hysingla ER 80 MG 24 HR Extended Release Oral TabletSYb7d23ac2-e776-9f62-3290-c64c2d6eb35316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59011-271-605901102716060 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59011-271-60) 2015-01-150000-00-00NoNoCurrent