FDA.reportPublic FDA data

NDC 70710-1127-01 - Ursodiol

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
70710-1127
Requested NDC
70710-1127-01
Package NDCs from labels
70710-1127-1, 70710-1127-5, 70710-1127-01
Manufacturer
American Health Packaging
Effective date
2025-11-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ursodiol - American Health PackagingAmerican Health Packaging2025-11-13HUMAN PRESCRIPTION DRUG LABEL
Ursodiol - Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences LimitedZydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited2024-03-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1127-1Ursodiol100 in 1 BOTTLETABLET1007
70710-1127-5Ursodiol500 in 1 BOTTLETABLET5007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1127URSODIOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]7Current NDC, Legacy NDC, 2 package rows20240323_55c1556b-8b47-479a-979b-fd61bdd27c7f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1127-1EA - Each70710-1127a19dd504-b31a-4415-8c68-8d7ff8a66d1d12019-01-24

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 98 of 139 · 2,772 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alumier MD Sheer HydrationTITANIUM DIOXIDE, ZINC OXIDEAlumier Labs2874e531-d647-339c-e063-6394a90ac86f2024-12-03WarningsExact identifier
unii: 15FIX9V2JP
Alumier MD Sheer Hydration Tinted Moisturizing SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa951ebe7-7786-38ef-e053-2995a90a70e32024-12-03WarningsExact identifier
unii: 15FIX9V2JP
MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50ZINC OXIDE, TITANIUM DIOXIDEExpanscience Laboratories d/b/a Mustelabeec926c-35a5-1901-e053-2a95a90ad0432024-12-02WarningsExact identifier
unii: 15FIX9V2JP
GeovitaCEREBRUM, CUPRUM MET, FERRUM MET, FORMICUM ACIDUM, SILICEARUBIMED AG0fcb5c06-d414-456c-a0ef-28e14018a7812024-11-29WarningsExact identifier
unii: ETJ7Z6XBU4
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d41602-9dcb-eaa8-e063-6394a90a7cfa2024-11-26WarningsExact identifier
unii: ETJ7Z6XBU4
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d4ddaf-9c07-a7fc-e063-6394a90adc0b2024-11-26WarningsExact identifier
unii: ETJ7Z6XBU4
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d5997b-1cae-41c2-e063-6394a90ac74a2024-11-26WarningsExact identifier
unii: ETJ7Z6XBU4
Ursodiol 200 mgUSODIOLLGM PHARMA SOLUTIONS, LLCebaaa3e2-1d80-4b40-b696-88cdd06448e42024-11-26Warnings, Adverse reactionsExact identifier
unii: 724L30Y2QR
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 9NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior95d657e5-cf89-48dd-a12e-f9664b131eb92024-11-25WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior33f42840-92f8-4fa1-86e9-ec0a06d637de2024-11-25WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior20785934-e534-4ea5-8c15-f9669b0421532024-11-25WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diore4464601-a9ec-413b-a883-9efe61f2f5b22024-11-25WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 8NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5e7c879c-1e5c-4614-bec1-d363978c3b0d2024-11-25WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5c1f1f09-19fb-4ceb-bb6d-22d51b5733a82024-11-25WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc8a48759-efac-47ac-972a-c994b6774e202024-11-25WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior793c18e5-4363-45b0-a184-0b6c69a91b2c2024-11-25WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior8a542b3c-c3c0-465a-9b24-6a62016656f32024-11-25WarningsExact identifier
unii: 15FIX9V2JP
SKIN LONG-WEAR WEIGHTLESS FOUNDATION BROAD SPECTRUM SPF 15OCTINOXATE AND TITANIUM DIOXIDEBobbi Brown Professional Cosmetics Inc.b669c36d-4c94-455d-8534-9c3bb024d6682024-11-25WarningsExact identifier
unii: 15FIX9V2JP
VITAMIN ENRICHED SKIN TINT BROAD SPECTRUM SPF 15VITAMIN ENRICHED SKIN TINT BROAD SPECTRUM SPF 15Bobbi Brown Professional Cosmetics Inc.eecb05ab-2048-6e8d-e053-2995a90a82802024-11-22WarningsExact identifier
unii: 15FIX9V2JP
Hempvana Ultra Pain Relief Homeopathic Cream Platinum - Nerve ReliefARNICA MONTANA, ACONITUM NAPELLUS, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, SECALE CORNUTUM, SILICEATELEBRANDS CORP2787f88c-752e-cbaa-e063-6394a90a732c2024-11-21WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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