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
12 HR hydrocodone bitartrate 10 MG Extended Release Oral Capsule
Full name
12 HR hydrocodone bitartrate 10 MG Extended Release Oral Capsule
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:03

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

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