FDA.reportPublic FDA data

12 HR hydrocodone bitartrate 10 MG Extended Release Oral Capsule

RxCUI
1860491
RxNorm name
12 HR hydrocodone bitartrate 10 MG Extended Release Oral Capsule
Display name
HYDROcodone XR (Oral Pill)
Full name
12 HR hydrocodone bitartrate 10 MG Extended Release Oral Capsule
Term type
SCD
Status
Active
Strength
10 mg
Dose form
12 HR XR Cap
Route
Oral Pill
Updated
2026-10-26 03:55:14

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012017
Active start
012017
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
hydrocodone bitartrate10 MG / 1 EACHhydrocodonehydrocodone bitartrate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Extended Release Oral Capsule316943

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
hydrocodone5489

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STR12 HR HYDROcodone bitartrate 10 MG Extended Release Oral Capsule1NAMES
RxNorm Name12 HR hydrocodone bitartrate 10 MG Extended Release Oral Capsule1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_IDa7b8ea07-e926-f0a5-c20d-92f23ed350d01CODES
RxCUI18604911CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
47781-409-6047781-409Hydrocodone Bitartrate Hydrocodone BitartrateAlvogen Inc.ANDA206986

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA20698647781-409Hydrocodone Bitartrate Hydrocodone BitartrateANDAAlvogen Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 2 matching rows.

NDC11, Source, Active table
NDC11SourceActive
47781040960rxnav_ndcsyes
65224091060rxnav_ndcsyes

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
6ccfbd98-7750-4955-a654-ec104fb666f9HYDROcodone bitartrate 10 MG 12HR Extended Release Oral Capsule [PSN] · 12 HR hydrocodone bitartrate 10 MG Extended Release Oral Capsule [SCD]220These highlights do not include all the information needed to use ZOHYDRO ® ER safely and effectively. See full prescribing information for ZOHYDRO ® ER. ZOHYDRO ® ER (hydrocodone bitartrate) extended‑release capsules, for oral use, CII Initial U.S. Approval: 194320150225
cf68f7fe-30a9-4f1a-a3a4-6352dc436bbeHYDROcodone bitartrate 10 MG 12HR Extended Release Oral Capsule [PSN] · 12 HR hydrocodone bitartrate 10 MG Extended Release Oral Capsule [SCD]213These highlights do not include all the information needed to use ZOHYDRO ® ER safely and effectively. See full prescribing information for ZOHYDRO ® ER. ZOHYDRO ® ER (hydrocodone bitartrate) extended‑release capsules, for oral use, CII Initial U.S. Approval: 194320140826
a7b8ea07-e926-f0a5-c20d-92f23ed350d0HYDROcodone bitartrate 10 MG 12HR Extended Release Oral Capsule [PSN] · 12 HR hydrocodone bitartrate 10 MG Extended Release Oral Capsule [SCD]29These highlights do not include all the information needed to use HYDROCODONE BITARTRATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for HYDROCODONE BITARTRATE EXTENDED-RELEASE CAPSULES. HYDROCODONE BITARTRATE extended-release capsules, for oral use, CII Initial U.S. Approval: 194320231219

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
a7b8ea07-e926-f0a5-c20d-92f23ed350d0These highlights do not include all the information needed to use HYDROCODONE BITARTRATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for HYDROCODONE BITARTRATE EXTENDED-RELEASE CAPSULES. HYDROCODONE BITARTRATE extended-release capsules, for oral use, CII Initial U.S. Approval: 1943Alvogen Inc. | Norwich Pharmaceuticals, Inc.20260131
a7b8ea07-e926-f0a5-c20d-92f23ed350d0These highlights do not include all the information needed to use HYDROCODONE BITARTRATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for HYDROCODONE BITARTRATE EXTENDED-RELEASE CAPSULES. HYDROCODONE BITARTRATE extended-release capsules, for oral use, CII Initial U.S. Approval: 1943Alvogen Inc. | Norwich Pharmaceuticals, Inc.20231219
a7b8ea07-e926-f0a5-c20d-92f23ed350d0These highlights do not include all the information needed to use HYDROCODONE BITARTRATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for HYDROCODONE BITARTRATE EXTENDED-RELEASE CAPSULES . HYDROCODONE BITARTRATE extended-release capsules, for oral use, CII Initial U.S. Approval: 1943Alvogen Inc. | Norwich Pharmaceuticals, Inc.20231219
5e65bb7d-749d-4cdc-acc2-20b302ad3a7fThese highlights do not include all the information needed to use Hydrocodone Bitartrate Extended-Release Capsules safely and effectively. See full prescribing information for Hydrocodone Bitartrate Extended-Release Capsules. Hydrocodone Bitartrate Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 1943Persion Pharmaceuticals LLC | Recro Gainesville LLC | Noramco, Inc | AndersonBrecon, Inc., d.b.a. Packaging Coordinators, Inc. Rockford (formerly Anderson Packaging, Inc.) | SGS Life Sciences Services | Eurofins Lancaster Laboratories, Inc. (previously Lancaster Laboratories, Inc.) | Mayne Pharma Inc. | Catalent Pharma Solutions (Catalent)20200114

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCR05DAOpium alkaloids and derivativesATC1-4hydrocodone
FDASPLN0000175690Opioid AgonistEPChas_epchydrocodone
FDASPLN0000000174Opioid AgonistsMOAhas_moahydrocodone
MEDRTD006853HydrocodoneCHEMhas_ingredienthydrocodone bitartrate
MEDRTD006853HydrocodoneCHEMhas_ingredienthydrocodone
MEDRTD001249AsthmaDISEASEci_withhydrocodone bitartrate
MEDRTD001249AsthmaDISEASEci_withhydrocodone
MEDRTD003371CoughDISEASEmay_treathydrocodone
MEDRTD003371CoughDISEASEmay_treathydrocodone bitartrate
MEDRTD004342Drug HypersensitivityDISEASEci_withhydrocodone bitartrate
MEDRTD004342Drug HypersensitivityDISEASEci_withhydrocodone
MEDRTD007415Intestinal ObstructionDISEASEci_withhydrocodone bitartrate
MEDRTD007415Intestinal ObstructionDISEASEci_withhydrocodone
MEDRTD008173Lung Diseases, ObstructiveDISEASEmay_treathydrocodone
MEDRTD008173Lung Diseases, ObstructiveDISEASEmay_treathydrocodone bitartrate
MEDRTD010149Postoperative PainDISEASEmay_treathydrocodone bitartrate
MEDRTD010149Postoperative PainDISEASEmay_treathydrocodone
MEDRTD012131Respiratory InsufficiencyDISEASEci_withhydrocodone bitartrate
MEDRTD012131Respiratory InsufficiencyDISEASEci_withhydrocodone
MEDRTN0000191866Opioid mu-Receptor AgonistsMOAhas_moahydrocodone bitartrate
MEDRTN0000191866Opioid mu-Receptor AgonistsMOAhas_moahydrocodone
MEDRTN0000175439AnalgesiaPEhas_pehydrocodone bitartrate
MEDRTN0000175439AnalgesiaPEhas_pehydrocodone
MEDRTN0000008501Decreased Central Nervous System Organized Electrical ActivityPEci_pehydrocodone bitartrate
MEDRTN0000008501Decreased Central Nervous System Organized Electrical ActivityPEci_pehydrocodone
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pehydrocodone
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pehydrocodone bitartrate
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_pehydrocodone
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_pehydrocodone bitartrate

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH10 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY12 HR
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE2
CODESANDAANDA206986
CODESVUID4033061
NAMESPrescribable SynonymHYDROcodone bitartrate 10 MG 12HR Extended Release Oral Capsule
NAMESTallman Synonym12 HR HYDROcodone bitartrate 10 MG Extended Release Oral Capsule
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File