NDC 68382-319-30 - TRAMADOL 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
68382-319
Requested NDC
68382-319-30
Package NDCs from labels
68382-319-01, 68382-319-05, 68382-319-10, 68382-319-30, 68382-319-77
Manufacturer
Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited
Effective date
2023-09-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TRAMADOL - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2023-09-14HUMAN PRESCRIPTION DRUG LABEL
TRAMADOL HYDROCHLORIDE - DirectRXDirectRX2023-06-06HUMAN PRESCRIPTION DRUG LABEL
TRAMADOL HYDROCHLORIDE - Bryant Ranch PrepackBryant Ranch Prepack2021-12-28HUMAN PRESCRIPTION DRUG LABEL
Tramadol Hydrochloride Tablets, USP C-IVNuCare Pharmaceuticals,Inc.2021-02-15HUMAN PRESCRIPTION DRUG LABEL
Tramadol Hydrochloride Tablets, USP C-IVNuCare Pharmaceuticals,Inc.2021-02-12HUMAN PRESCRIPTION DRUG LABEL
Tramadol 50mgRedPharm Drug, Inc.2021-01-14HUMAN PRESCRIPTION DRUG LABEL
TRAMADOL HYDROCHLORIDE - Major PharmaceuticalsMajor Pharmaceuticals2019-11-02HUMAN PRESCRIPTION DRUG LABEL
TRAMADOL HYDROCHLORIDE - Proficient Rx LPProficient Rx LP2019-10-01HUMAN PRESCRIPTION DRUG LABEL
TRAMADOL HYDROCHLORIDE - Clinical Solutions Wholesale, LLCClinical Solutions Wholesale, LLC2019-07-12HUMAN PRESCRIPTION DRUG LABEL
ANHYDROUS LACTOSE - St. Mary's Medical Park Pharmacy | CADILA HEALTHCARE LIMITEDSt. Mary's Medical Park Pharmacy | CADILA HEALTHCARE LIMITED2019-05-13HUMAN PRESCRIPTION DRUG LABEL
Tramadol Hydrochloride Tablets, USP C-IVPreferred Pharmaceuticals Inc.2019-03-05HUMAN PRESCRIPTION DRUG LABEL
Tramadol HCl - Northwind Pharmaceuticals | EPM RepackagingNorthwind Pharmaceuticals | EPM Repackaging2017-10-03HUMAN PRESCRIPTION DRUG LABEL
TRAMADOL HYDROCHLORIDE - Contract Pharmacy Services-PA | Coupler EnterprisesContract Pharmacy Services-PA | Coupler Enterprises2017-08-31HUMAN PRESCRIPTION DRUG LABEL
Tramadol Hydrochloride Tablets, USP C-IVNuCare Pharmaceuticals, Inc.2017-08-11HUMAN PRESCRIPTION DRUG LABEL
Tramadol Hydrochloride Tablets, USP C-IVNuCare Pharmaceuticals, Inc.2017-05-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-319-01EA - Each68382-319f31f0e0e-983f-42cb-944f-e6d3029a9d9a12012-07-24
68382-319-05EA - Each68382-319e7b1f07b-c5f3-454b-aa30-10ee46e2448912012-07-24
68382-319-10EA - Each68382-319dd367050-33b9-453e-82ae-708ebae7443412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]2
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]2
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q621TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XTRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ATRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
SHELLACINACTIVE INGREDIENT46N107B71OTRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]1

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 2 of 146 · 2,903 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSHodayfa Abu Alkian524e002c-f509-9395-e063-6394a90acd9e2026-08-20WarningsExact identifier
unii: 5138Q19F1X
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSShenzhen Leadtop E-commerce Co.,Ltd.558e8629-6a8d-198d-e063-6294a90ac5fc2026-08-19WarningsExact identifier
unii: 5138Q19F1X
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Smelling SaltAMMONIAShenzhen Jufeng Qisheng Technology Co., Ltd.44e1b2c1-f524-782c-e063-6394a90ad1e42026-08-18WarningsExact identifier
unii: 5138Q19F1X
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Agri-ChordARSENICUM ALB, BELLADONNA, CALC CARB, CEANOTHUS, CHELIDONIUM MAJ, CUPRUM SULPH, FUMARICUM AC, GALIUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, KALI IOD, LYCOPODIUM, PANCREAS SUIS, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, PHYTOLACCA, SARSAPARILLA, SILICEA, SULPHUR, THYROIDINUM, TRIFOLIUM PRAT, XANTHOXYLUM, ZINC PHOSEnergetix Corporation9eb50e9a-3528-4809-bd76-47d99ef03f0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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