Tetracycline Hydrochloride

Product NDC
0591-2475
11-digit product format
005912475
Labeler code
0591
Product ID
0591-2475_e13661d8-d500-46cd-995d-529adac77bda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tetracycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA061837
Marketing category
ANDA
Marketing start
2011-08-15
Substance
TETRACYCLINE HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tetracycline Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRACYCLINE HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP6R62377KV
Rxcui198250, 198252

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-2475-01Tetracycline Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE10020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2475-01EA - Each0591-24750679664f-fc5d-48d4-aae0-3cefadd424a212016-06-14

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
0591-2475TETRACYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]19Current NDC, Legacy NDC, 1 package rows20250509_32a409a0-fea6-411a-8218-c1c7df46d664.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198250tetracycline HCl 250 MG Oral CapsulePSN32a409a0-fea6-411a-8218-c1c7df46d66420
198252tetracycline HCl 500 MG Oral CapsulePSN32a409a0-fea6-411a-8218-c1c7df46d66420
198250tetracycline hydrochloride 250 MG Oral CapsuleSCD32a409a0-fea6-411a-8218-c1c7df46d66420
198252tetracycline hydrochloride 500 MG Oral CapsuleSCD32a409a0-fea6-411a-8218-c1c7df46d66420
198252tetracycline (as tetracycline hydrochloride) 500 MG Oral CapsuleSY32a409a0-fea6-411a-8218-c1c7df46d66420
198252tetracycline HCl 500 MG Oral CapsuleSY32a409a0-fea6-411a-8218-c1c7df46d66420
198252tetracycline HCl 500 MG Oral CapsulePSN4202cbfb-52e9-47f2-bd3a-1003319ca3cb1
198252tetracycline HCl 500 MG Oral CapsulePSNedf54a38-41a7-42ec-a05f-46ab20cb6fc31
198252tetracycline hydrochloride 500 MG Oral CapsuleSCD4202cbfb-52e9-47f2-bd3a-1003319ca3cb1
198252tetracycline hydrochloride 500 MG Oral CapsuleSCDedf54a38-41a7-42ec-a05f-46ab20cb6fc31
198252tetracycline (as tetracycline hydrochloride) 500 MG Oral CapsuleSY4202cbfb-52e9-47f2-bd3a-1003319ca3cb1
198252tetracycline (as tetracycline hydrochloride) 500 MG Oral CapsuleSYedf54a38-41a7-42ec-a05f-46ab20cb6fc31
198252tetracycline HCl 500 MG Oral CapsuleSY4202cbfb-52e9-47f2-bd3a-1003319ca3cb1
198252tetracycline HCl 500 MG Oral CapsuleSYedf54a38-41a7-42ec-a05f-46ab20cb6fc31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-2475-0100591247501100 CAPSULE in 1 BOTTLE, PLASTIC (0591-2475-01) 100 capsule2011-08-150000-00-00NoNoCurrent