NDC 52959-669 - Sentraflox AM-10

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: 52959-669
Package NDCs from labels: 52959-669-30
Manufacturer: Physician Therapeutics LLC | Pliva | H.J. Harkins Company, Inc. | Targeted Medical Pharma, Inc.
Effective date: 2011-08-17
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Sentraflox AM-10	Physician Therapeutics LLC \| Pliva \| H.J. Harkins Company, Inc. \| Targeted Medical Pharma, Inc.	2011-08-17	HUMAN PRESCRIPTION DRUG LABEL
Sentroxatine	Physician Therapeutics LLC \| Pliva \| H.J. Harkins Company, Inc \| Targeted Medical Pharma, Inc.	2011-08-01	HUMAN PRESCRIPTION DRUG LABEL
Gaboxetine	Physician Therapeutics LLC \| Pliva \| 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
52959-669-30	Sentroxatine	30 in 1 BOTTLE	CAPSULE	30	10 mg	9
52959-669-30	Sentraflox AM-10	30 in 1 BOTTLE	CAPSULE	30	10 mg	9
52959-669-30	Gaboxetine	30 in 1 BOTTLE	CAPSULE	30	10 mg	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-669	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9	Unmatched	20110818_35fee753-acd7-4da2-bd60-973dc6c0b21f.zip
52959-669	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9	Unmatched	20110815_83df297b-6467-451e-af4d-2c1f996cd009.zip
52959-669	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8	Unmatched	20110815_52057058-abdb-44ed-b60d-a718c97fbfda.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHOLINE	ACTIVE INGREDIENT	N91BDP6H0X	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
CHOLINE	ACTIVE INGREDIENT	N91BDP6H0X	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
CHOLINE	ACTIVE MOIETY	N91BDP6H0X	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
CHOLINE	ACTIVE MOIETY	N91BDP6H0X	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
GELATIN	INACTIVE INGREDIENT	2G86QN327L	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
GELATIN	INACTIVE INGREDIENT	2G86QN327L	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
SHELLAC	INACTIVE INGREDIENT	46N107B71O	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
SHELLAC	INACTIVE INGREDIENT	46N107B71O	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SENTRAFLOX AM-10 (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SENTROXATINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	9
CHOLINE	ACTIVE INGREDIENT	N91BDP6H0X	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
FLUOXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	I9W7N6B1KJ	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
CHOLINE	ACTIVE MOIETY	N91BDP6H0X	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
FLUOXETINE	ACTIVE MOIETY	01K63SUP8D	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GABOXETINE (FLUOXETINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GABOXETINE (FLUOXETINE HYDROCHLORIDE, 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 87 of 114 · 2,263 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Proceuticals Private Label by TiZO tinted mineral sunscreen stick	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, Ltd	2179a2ff-9425-5b2c-e063-6294a90a45b6	2024-09-06	Warnings	Exact identifier unii: 15FIX9V2JP
EltaMD UV Physical Rosy Tint SPF40	TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc	6bc4d2d4-ef62-4ec0-b514-17257603bac2	2024-09-05	Warnings	Exact identifier unii: 15FIX9V2JP
ammonia inhalants	INHALANT	Epic Medical Supply Corp	20e849e5-8517-b9fd-e063-6394a90a0d23	2024-09-03	Warnings	Exact identifier unii: 5138Q19F1X
Proceuticals Private Label by TiZO non-tinted mineral sunscreen stick	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, Ltd	20e86260-d641-c9ac-e063-6394a90ac07d	2024-08-30	Warnings	Exact identifier unii: 15FIX9V2JP
Freaks of Nature Peak Performance SPF50	FREAKS OF NATURE PEAK PERFORMANCE SPF50	Milbar Laboratories	20b18cea-95e9-3527-e063-6294a90a4db4	2024-08-30	Warnings	Exact identifier unii: 15FIX9V2JP
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	e15646e0-a431-4b3d-8d6f-7a3d0dadfcc6	2024-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 310384 unii: I9W7N6B1KJ
Fluoxetine	FLUOXETINE HYDROCHLORIDE	Bryant Ranch Prepack	3d5d03ff-0d0c-429f-b747-31ff3465d39d	2024-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 310385 unii: I9W7N6B1KJ
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30	TITANIUM DIOXIDE AND ZINC OXIDE	Dermio Dermatology LLC	204973ce-dba4-8235-e063-6394a90a015c	2024-08-22	Warnings	Exact identifier unii: 15FIX9V2JP
MACKENZIES OCEAN SAFE SUNSCREEN	TITANIUM DIOXIDE	Naturally Uncommon, LLC	1fd0a790-c66c-216f-e063-6294a90ae971	2024-08-16	Warnings	Exact identifier unii: 15FIX9V2JP
Fluoxetine	FLUOXETINE HYDROCHLORIDE	A-S Medication Solutions	1226a67f-ec09-42f6-9d1b-9ddd862ea0a0	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 310384 unii: I9W7N6B1KJ
Proceuticals Private Label by TiZO non-tinted foaming mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, Ltd	1f4491ab-95b0-cc14-e063-6394a90a73ca	2024-08-09	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b737146d-fb50-4ed6-ab5e-6aff3393992a	2024-08-07	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	54b07420-6a30-4481-99f5-a7d6a4df898c	2024-08-07	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	65659277-cd30-453c-929e-3651c9f19da8	2024-08-07	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	28ae9c39-eb79-4a19-8149-af8d8e7901ae	2024-08-07	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6.5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	05f7119a-0c92-4393-a62d-8e84ec451d20	2024-08-07	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b90ee1ba-17b5-4367-9df3-e9e27217960c	2024-08-07	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	ad5c5121-d75d-449d-a4db-a7b074787f68	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 00	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	0018573d-922b-4642-9513-63481e9131d5	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	83b20b0d-c2db-4720-8434-57b73847ebca	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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