NDC 52959-378 - Trazamine

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: 52959-378
Package NDCs from labels: 52959-378-30
Manufacturer: Physician Therapeutics LLC | Targeted Medical Pharma, Inc. | Pliva Hrvatska d.o.o. | H.J. Harkins Company, Inc.
Effective date: 2011-08-01
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Trazamine	Physician Therapeutics LLC \| Targeted Medical Pharma, Inc. \| Pliva Hrvatska d.o.o. \| H.J. Harkins Company, Inc.	2011-08-01	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52959-378-30	Trazamine	30 in 1 BOTTLE	TABLET	30	50 mg	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-378	TRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	11	Unmatched	20110812_d5f0457f-b722-48b7-8901-61da7fbb4090.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHOLINE	ACTIVE INGREDIENT	N91BDP6H0X	TRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	11
TRAZODONE HYDROCHLORIDE	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	11
CHOLINE	ACTIVE MOIETY	N91BDP6H0X	TRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	11
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	11
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	11
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	11
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	TRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	11
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAZAMINE (TRAZODONE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	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 31 of 35 · 683 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Defend Cold and Mucus	BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PATENS, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE	Hyland's Inc.	bb851be1-0528-4199-91e7-e09f994b2862	2022-12-12	Warnings	Exact identifier unii: ETJ7Z6XBU4
Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic Combination	CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA	OHM PHARMA INC.	044a7174-f7a3-490f-9cad-01f2665d7575	2022-12-02	Warnings	Exact identifier unii: ETJ7Z6XBU4
4 Kids Cold and Mucus Nighttime	EUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFUR	Hyland's Inc.	6f7b2585-2f0e-5938-e053-2a91aa0aa9d1	2022-11-21	Warnings	Exact identifier unii: ETJ7Z6XBU4
4 Kids Complete Cold and Mucus	BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE	Hyland's Inc.	ef39fe3d-a42d-4baa-9199-91f664feb432	2022-11-21	Warnings	Exact identifier unii: ETJ7Z6XBU4
Hendel Periodontal and Tooth Pain Relief	SODIUM BORATE, TRIBASIC CALCIUM PHOSPHATE, MERCURIUS SOLUBILIS, AND SILICON DIOXIDE	MediNatura Inc	f34e9f77-69fd-4c7f-9eea-2d721a4d27fb	2022-08-22	Warnings	Exact identifier unii: ETJ7Z6XBU4
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Proficient Rx LP	a90caa68-b28e-425f-b77c-7b566ac17dc2	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 6E8ZO8LRNM
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Proficient Rx LP	f6c3fb84-5b68-4675-a853-fe49bfbf3f9f	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA071523 rxcui: 856377 unii: 6E8ZO8LRNM
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Proficient Rx LP	2a1d0989-6ed5-4a2f-bd03-73d61eb40232	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 856377 unii: 6E8ZO8LRNM
ALPHA SH	SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS	Schwabe Mexico, S.A. de C.V.	3e2e5f52-db54-4635-83a8-a67a683c093c	2022-03-22	Warnings	Exact identifier unii: ETJ7Z6XBU4
ALPHA SH	SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS	Schwabe North America, Inc.	94de9ce3-6ee9-4322-bda2-0b4391f09d87	2022-03-22	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ear Care	ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM	Newton Laboratories, Inc.	da807eb3-34a3-61b9-e053-2995a90a0e21	2022-03-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ear Care	INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	da80a5ea-f603-719e-e053-2995a90a9710	2022-03-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ear Care	INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	da81b21a-090a-dabf-e053-2995a90aa05e	2022-03-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ear Care	INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	da821d05-b2f0-3582-e053-2a95a90afe59	2022-03-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ear Care	ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM	Newton Laboratories, Inc.	da717cf0-54af-c4e2-e053-2995a90ac97c	2022-03-17	Warnings	Exact identifier unii: ETJ7Z6XBU4
ACNE HP	CARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINC	Natural Creations, Inc.	b2368ab6-e233-4473-99fa-86e1fbc2a879	2022-02-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
EAR RX	ACONITUM NAP, BARYTA CARB, BELLADONNA, CALC CARB, CAPSICUM, CARBO VEG, CAUSTICUM, CHAMOMILLA, FERRUM PHOS, HEPAR SULPH CALC, KALI MUR, LACHESIS, LYCOPODIUM, MERCURIUS SOL, NATRUM MUR, PLANTAGO, PULSATILLA, SILICEA, SULPHUR, VERBASCUM	Miami Beach Pediatrics pa	a8753f88-4b8a-472f-a4bd-f2e9cec83610	2021-12-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
Lyme Disease Support 2	ARGENTUM NITRICUM, ASTRAGALUS MENZIESII, CALCAREA SULPHURICA, CUPRUM ARSENICOSUM, DNA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI SULPHURICUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, RNA, SILICEA.	OHM PHARMA INC.	13b4b78b-f9f7-4cf6-8f43-61679160086b	2021-12-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
Lyme Disease Support 1	ALUMEN, CALCAREA CARBONICA, DNA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI CARBONICUM, KALI MURIATICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, RNA, SILICEA.	OHM PHARMA INC.	035e75d6-aeef-4dfd-b076-9d3d8e4a5086	2021-12-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
OHM Skin Healing Cream	CALENDULA OFFICINALIS, STELLARIA MEDIA, CALCAREA SULPHURICA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, SILICEA, SYMPHYTUM OFFICINALE, THIOSINAMIUM, HAMAMELIS VIRGINIANA.	OHM PHARMA INC.	c12e6706-37f0-4900-856c-fc7e7ac3b724	2021-12-29	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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