Tetracycline Hydrochloride

Product NDC
53808-0877
11-digit product format
538080877
Labeler code
53808
Product ID
53808-0877_2c92f80c-2f2d-472c-9937-ee9c4e6ab1a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tetracycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA061837
Marketing category
ANDA
Marketing start
2013-01-01
Marketing end
0000-00-00
Substance
TETRACYCLINE HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Tetracycline-class Antimicrobial [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
151122cd-8b80-4972-8b02-3a4dda642fbcProduct name220200701
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0877-22020-01-31C16284748780-19d75b9d0-7b4c-f424-e053-dadaa90a57ceTETRACYCLINE HYDROCHLORIDE CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0877-2Tetracycline Hydrochloride60 in 1 BLISTER PACKCAPSULE601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TETRACYCLINE HYDROCHLORIDEACTIVE INGREDIENTP6R62377KVTETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TETRACYCLINEACTIVE MOIETYF8VB5M810TTETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MTETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHTETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OTETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFTETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTIDK7C2HS09TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GELATININACTIVE INGREDIENT2G86QN327LTETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GTETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SHELLACINACTIVE INGREDIENT46N107B71OTETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INTETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
WATERINACTIVE INGREDIENT059QF0KO0RTETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0877TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20140415_edf54a38-41a7-42ec-a05f-46ab20cb6fc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198252tetracycline HCl 500 MG Oral CapsulePSNedf54a38-41a7-42ec-a05f-46ab20cb6fc31
198252tetracycline hydrochloride 500 MG Oral CapsuleSCDedf54a38-41a7-42ec-a05f-46ab20cb6fc31
198252tetracycline (as tetracycline hydrochloride) 500 MG Oral CapsuleSYedf54a38-41a7-42ec-a05f-46ab20cb6fc31
198252tetracycline HCl 500 MG Oral CapsuleSYedf54a38-41a7-42ec-a05f-46ab20cb6fc31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0877-25380808770260 in 1 BLISTER PACKHistorical