NDC 52959-457 - Gabazolamine-0.5

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: 52959-457
Package NDCs from labels: 52959-457-30
Manufacturer: Physician Therapeutics LLC | Sandoz Inc | H.J. Harkins Company, Inc | Targeted Medical Pharma 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
Gabazolamine-0.5	Physician Therapeutics LLC \| Sandoz Inc \| H.J. Harkins Company, Inc \| Targeted Medical Pharma 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
52959-457-30	Gabazolamine-0.5	30 in 1 BOTTLE	TABLET	30	0.5 mg	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-457	GABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8	Unmatched	20110812_c4b5257a-4dfa-4a58-a05b-c0a32dbb9352.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALPRAZOLAM	ACTIVE INGREDIENT	YU55MQ3IZY	GABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
CHOLINE	ACTIVE INGREDIENT	N91BDP6H0X	GABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
ALPRAZOLAM	ACTIVE MOIETY	YU55MQ3IZY	GABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
CHOLINE	ACTIVE MOIETY	N91BDP6H0X	GABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	GABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	GABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	GABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	GABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8

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 22 of 22 · 423 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Additox	TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM	BioActive Nutritional, Inc.	319ee2fe-58e3-495e-bf0d-df201f6fbb1c	2018-07-18	Warnings	Exact identifier unii: OJ245FE5EU
Alprazolam	ALPRAZOLAM	Aphena Pharma Solutions - Tennessee, LLC	964d7f43-34a6-45af-a95f-3b9ade17c6a5	2018-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 197321 rxcui: 308047 rxcui: 308048 unii: YU55MQ3IZY
2adb76a0-44f1-45cc-98db-352f41f042c5			c4b5257a-4dfa-4a58-a05b-c0a32dbb9352	2011-08-01	Warnings, Adverse reactions	Exact identifier spl id: 2adb76a0-44f1-45cc-98db-352f41f042c5 spl set id: c4b5257a-4dfa-4a58-a05b-c0a32dbb9352

Reported adverse events (FAERS/openFDA)#

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