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
Label	Manufacturer	Effective date	Type
TRAMADOL - Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2023-09-14	HUMAN PRESCRIPTION DRUG LABEL
TRAMADOL HYDROCHLORIDE - DirectRX	DirectRX	2023-06-06	HUMAN PRESCRIPTION DRUG LABEL
TRAMADOL HYDROCHLORIDE - Bryant Ranch Prepack	Bryant Ranch Prepack	2021-12-28	HUMAN PRESCRIPTION DRUG LABEL
Tramadol Hydrochloride Tablets, USP C-IV	NuCare Pharmaceuticals,Inc.	2021-02-15	HUMAN PRESCRIPTION DRUG LABEL
Tramadol Hydrochloride Tablets, USP C-IV	NuCare Pharmaceuticals,Inc.	2021-02-12	HUMAN PRESCRIPTION DRUG LABEL
Tramadol 50mg	RedPharm Drug, Inc.	2021-01-14	HUMAN PRESCRIPTION DRUG LABEL
TRAMADOL HYDROCHLORIDE - Major Pharmaceuticals	Major Pharmaceuticals	2019-11-02	HUMAN PRESCRIPTION DRUG LABEL
TRAMADOL HYDROCHLORIDE - Proficient Rx LP	Proficient Rx LP	2019-10-01	HUMAN PRESCRIPTION DRUG LABEL
TRAMADOL HYDROCHLORIDE - Clinical Solutions Wholesale, LLC	Clinical Solutions Wholesale, LLC	2019-07-12	HUMAN PRESCRIPTION DRUG LABEL
ANHYDROUS LACTOSE - St. Mary's Medical Park Pharmacy \| CADILA HEALTHCARE LIMITED	St. Mary's Medical Park Pharmacy \| CADILA HEALTHCARE LIMITED	2019-05-13	HUMAN PRESCRIPTION DRUG LABEL
Tramadol Hydrochloride Tablets, USP C-IV	Preferred Pharmaceuticals Inc.	2019-03-05	HUMAN PRESCRIPTION DRUG LABEL
Tramadol HCl - Northwind Pharmaceuticals \| EPM Repackaging	Northwind Pharmaceuticals \| EPM Repackaging	2017-10-03	HUMAN PRESCRIPTION DRUG LABEL
TRAMADOL HYDROCHLORIDE - Contract Pharmacy Services-PA \| Coupler Enterprises	Contract Pharmacy Services-PA \| Coupler Enterprises	2017-08-31	HUMAN PRESCRIPTION DRUG LABEL
Tramadol Hydrochloride Tablets, USP C-IV	NuCare Pharmaceuticals, Inc.	2017-08-11	HUMAN PRESCRIPTION DRUG LABEL
Tramadol Hydrochloride Tablets, USP C-IV	NuCare Pharmaceuticals, Inc.	2017-05-22	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-319-01	EA - Each	68382-319	f31f0e0e-983f-42cb-944f-e6d3029a9d9a	1	2012-07-24
68382-319-05	EA - Each	68382-319	e7b1f07b-c5f3-454b-aa30-10ee46e24489	1	2012-07-24
68382-319-10	EA - Each	68382-319	dd367050-33b9-453e-82ae-708ebae74434	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	2
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	2
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2
POLYETHYLENE GLYCOL 1000	INACTIVE INGREDIENT	U076Q6Q621	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	2
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
CELLULOSE ACETATE	INACTIVE INGREDIENT	3J2P07GVB6	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL 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 1 of 146 · 2,903 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lymph Tonic II	ECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANA	BioActive Nutritional, Inc.	0e3265b0-b210-4a4c-80d2-8a9712981d4e	2026-09-17	Warnings	Exact identifier unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	W Aesthetics	5b0f2c8f-d6fa-5e25-e063-6394a90a084d	2026-09-09	Warnings	Exact identifier unii: 15FIX9V2JP
Psoriasis Control	CENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDE	Forces of Nature	2db33771-0bb9-49f8-84fa-dddc28e4ba26	2026-09-04	Warnings	Exact identifier unii: ETJ7Z6XBU4
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	c6104e62-5b2c-41a1-afb3-00dcf267a384	2026-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 835603 unii: 9N7R477WCK
BMNP Silicea	SILICEA	Total Operations Management LLC DBA:Bestmade Natural Products Micro	5a58454f-aed6-24ba-e063-6294a90a47fb	2026-08-31	Warnings	Exact identifier unii: ETJ7Z6XBU4
tramadol hydrochloride	TRAMADOL HYDROCHLORIDE	Strides Pharma Science Limited	a6cbd5de-8ae5-49e3-b89b-e35536b115d8	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 835603 unii: 9N7R477WCK
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50	SUNSCREEN SPF50	Guangzhou Meixi Biotechnology Co., Ltd.	5a0b4bd2-f6ad-35dc-e063-6294a90a8a66	2026-08-27	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO Hydrating Lightweight Sunscreen	AVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDE	Guangdong Aimu Biological Technology Co., Ltd	59eeaea1-d726-99f3-e063-6394a90aeea3	2026-08-26	Warnings	Exact identifier unii: 15FIX9V2JP
Argentum Quartz	ARGENTUM QUARTZ	Uriel Pharmacy Inc.	765c8c8f-0727-45da-a77e-c3907a3d0793	2026-08-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Endometrium Argentum	ENDOMETRIUM ARGENTUM	Uriel Pharmacy Inc	d2d1428a-c8b5-9529-e053-2995a90a2343	2026-08-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
S12 AIRBORNE	ALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEAT	Apex Energetics Inc.	bb0036c3-1e4d-5750-e053-2995a90ae895	2026-08-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Aurobindo Pharma Limited	e5005d9e-91cb-4ff8-bcf2-b5ee70cf4f3f	2026-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 835603 unii: 9N7R477WCK
Q Skin Science	SUNSCREEN	International Cosmeceuticals, Inc	59e4c3d0-ee4c-2350-e063-6394a90ac9d2	2026-08-25	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO zinc stick(GREEN)	TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE	Guangzhou Haishi Biological Technology Co., Ltd.	59c70c82-f7ff-9a04-e063-6294a90a7b3d	2026-08-24	Warnings	Exact identifier unii: 15FIX9V2JP
Smelling Salts	AMMONIA	Shenzhen Finona Information Technology Co., Ltd	3874ec89-0f1d-87b9-e063-6394a90a300a	2026-08-24	Warnings	Exact identifier unii: 5138Q19F1X
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01	ZINC OXIDE, TITANIUM DIOXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	59d74e3f-e3fa-a7a9-e063-6294a90a76e5	2026-08-24	Warnings	Exact identifier unii: 15FIX9V2JP
Aging Eye Formula	CINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUM	Nutritional Specialties, Inc.	d5b44f79-5299-4b31-ba45-0e511cdbe17c	2026-08-24	Warnings	Exact identifier unii: ETJ7Z6XBU4
Rohto Optic Glow	NAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOL	The Mentholatum Company	df9c5f7c-96e6-4b2b-b8cb-21a6a3342dff	2026-08-20	Warnings	Exact identifier unii: 6DC9Q167V3
Rohto All-In-One	HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE	The Mentholatum Company	43e690e4-b381-46e3-838c-33aef5bdadde	2026-08-20	Warnings	Exact identifier unii: 3NXW29V3WO
Rohto Max Strength	NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80	The Mentholatum Company	e4b49550-1ca3-4bd7-854d-409b53fa5e26	2026-08-20	Warnings	Exact identifier unii: 6OZP39ZG8H

Reported adverse events (FAERS/openFDA)#

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