FDA.reportPublic FDA data

NDC 70710-1111-08 - tizanidine hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70710-1111
Requested NDC
70710-1111-08
Package NDCs from labels
70710-1111-8, 70710-1111-5, 70710-1111-4, 70710-1111-08
Manufacturer
Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Limited
Effective date
2025-12-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TIZANIDINE - Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Limited2025-12-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1111-4tizanidine hydrochloride10 in 1 BLISTER PACKCAPSULE107
70710-1111-4tizanidine hydrochloride10 in 1 CARTONCAPSULE107
70710-1111-5tizanidine hydrochloride500 in 1 BOTTLECAPSULE5007
70710-1111-8tizanidine hydrochloride150 in 1 BOTTLECAPSULE1507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1111TIZANIDINE HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]6Current NDC, Legacy NDC, 4 package rows20241210_146c853c-99a8-4bf3-b1e3-be6876abe6ff.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1111-8EA - Each70710-1111c63cd87c-7044-4d00-a265-2d6fda29a70e12017-08-11

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 54 of 137 · 2,736 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non-Tinted Mineral StickTITANIUM DIOXIDE, ZINC OXIDEShelley Bennett Skincare326e9a14-5fb6-6a6e-e063-6294a90adece2025-12-10Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35bafa0b-d253-c263-e063-6394a90ad1e42025-12-10Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35ba578f-a842-7eec-e063-6394a90a11652025-12-10Exact identifier
unii: 15FIX9V2JP
Non Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35bc3994-1f72-2bbf-e063-6294a90ac2f12025-12-10Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35bccadf-6fc8-abd0-e063-6294a90aaa2e2025-12-10Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35bd61ff-0d66-a9b3-e063-6394a90ad9402025-12-10Exact identifier
unii: 15FIX9V2JP
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC31177bbd-68b0-8b24-e063-6294a90aa8d82025-12-10WarningsExact identifier
unii: 15FIX9V2JP
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC3117e138-83a1-0931-e063-6394a90abe432025-12-10WarningsExact identifier
unii: 15FIX9V2JP
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC31188175-a4ca-449f-e063-6394a90a3c052025-12-10WarningsExact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral Foaming SunscreenTITANIUM DIOXIDE, ZINC OXIDERestore Skin Therapy, LLC364b6af2-a0ed-4a17-e063-6394a90a3a172025-12-10Exact identifier
unii: 15FIX9V2JP
Sheer Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342b2403-4f4a-3e77-e063-6294a90a4f0a2025-12-10Exact identifier
unii: 15FIX9V2JP
Sheer Mineral Sunscreen BarTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342b69d5-f0e1-99cd-e063-6294a90abb6e2025-12-10Exact identifier
unii: 15FIX9V2JP
Sheer Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342c3f42-c17f-f777-e063-6394a90a80582025-12-10Exact identifier
unii: 15FIX9V2JP
Lip SPFTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396d3fdd-99d8-77e8-e063-6294a90aec2f2025-12-10Exact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396cae82-7641-e1b2-e063-6394a90a7c072025-12-10Exact identifier
unii: 15FIX9V2JP
Solar Knight SPF 40 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDEMASCARENAS ENTERPRISES, INC.36c27c91-22ac-205c-e063-6294a90ab3792025-12-10Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396ce15a-06ad-4055-e063-6294a90a27fb2025-12-10Exact identifier
unii: 15FIX9V2JP
tizanidine hydrochlorideTIZANIDINE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.146c853c-99a8-4bf3-b1e3-be6876abe6ff2025-12-10Warnings, Adverse reactionsExact identifier
application number: ANDA208622
ndc (package): 70710-1111-4
ndc (package): 70710-1112-5
ndc (package): 70710-1113-4
ndc (package): 70710-1111-8
ndc (package): 70710-1112-8
ndc (package): 70710-1113-8
ndc (package): 70710-1113-5
ndc (package): 70710-1112-4
ndc (package): 70710-1111-5
ndc (product): 70710-1113
ndc (product): 70710-1112
ndc (product): 70710-1111
ndc11 (package): 70710111108
rxcui: 485485
rxcui: 485486
rxcui: 485484
spl id: a619e873-810c-450b-bd4e-de0541ed3e63
spl set id: 146c853c-99a8-4bf3-b1e3-be6876abe6ff
unii: B53E3NMY5C
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.242ff053-b8c0-4f90-e063-6294a90a7bb32025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 13 IVORYOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247ef1f8-ad12-4f80-e063-6394a90a3e3c2025-12-09WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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