Tetracycline Hydrochloride

Product NDC
0440-8505
11-digit product format
004408505
Labeler code
0440
Product ID
0440-8505_6900fe26-43eb-4ef1-ad0b-52eaabee63aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tetracycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA060704
Marketing category
ANDA
Marketing start
2000-01-31
Marketing end
0000-00-00
Substance
TETRACYCLINE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Tetracycline-class Antimicrobial [EPC],Tetracyclines [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
0440-8505-912020-01-31C16284748780-19d75b9d0-8485-f424-e053-dadaa90a57ceTETRACYCLINE HYDROCHLORIDE CAPSULES USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-8505-91Tetracycline Hydrochloride120 in 1 BOTTLECAPSULE1201

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TETRACYCLINE HYDROCHLORIDEACTIVE INGREDIENTP6R62377KVTETRACYCLINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
TETRACYCLINEACTIVE MOIETYF8VB5M810TTETRACYCLINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933TETRACYCLINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTETRACYCLINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTETRACYCLINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTETRACYCLINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATETRACYCLINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TETRACYCLINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TETRACYCLINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LTETRACYCLINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TETRACYCLINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OTETRACYCLINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TETRACYCLINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTETRACYCLINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTETRACYCLINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTETRACYCLINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-8505TETRACYCLINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20130906_6f363d06-2400-43be-8fe5-69246c0fdc49.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198250tetracycline HCl 250 MG Oral CapsulePSN6f363d06-2400-43be-8fe5-69246c0fdc491
198250tetracycline hydrochloride 250 MG Oral CapsuleSCD6f363d06-2400-43be-8fe5-69246c0fdc491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-8505-9100440850591120 in 1 BOTTLEHistorical