FDA.reportPublic FDA data

Tetracycline Hydrochloride

Product NDC
52959-336
11-digit product format
529590336
Labeler code
52959
Product ID
52959-336_b921807d-5d59-4548-af3c-4152820b1465
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tetracycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA060704
Marketing category
ANDA
Marketing start
2010-03-23
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
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
52959-336-142020-01-31C16284748780-19d75b9d0-0136-f424-e053-dadaa90a57ceTETRACYCLINE HYDROCHLORIDE CAPSULES USP
52959-336-202020-01-31C16284748780-19d75b9d0-0136-f424-e053-dadaa90a57ceTETRACYCLINE HYDROCHLORIDE CAPSULES USP
52959-336-282020-01-31C16284748780-19d75b9d0-0136-f424-e053-dadaa90a57ceTETRACYCLINE HYDROCHLORIDE CAPSULES USP
52959-336-302020-01-31C16284748780-19d75b9d0-0136-f424-e053-dadaa90a57ceTETRACYCLINE HYDROCHLORIDE CAPSULES USP
52959-336-402020-01-31C16284748780-19d75b9d0-0136-f424-e053-dadaa90a57ceTETRACYCLINE HYDROCHLORIDE CAPSULES USP
52959-336-562020-01-31C16284748780-19d75b9d0-0136-f424-e053-dadaa90a57ceTETRACYCLINE HYDROCHLORIDE CAPSULES USP
52959-336-902020-01-31C16284748780-19d75b9d0-0136-f424-e053-dadaa90a57ceTETRACYCLINE HYDROCHLORIDE CAPSULES USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-336-14Tetracycline Hydrochloride14 in 1 BOTTLE, PLASTICCAPSULE141
52959-336-20Tetracycline Hydrochloride20 in 1 BOTTLE, PLASTICCAPSULE201
52959-336-28Tetracycline Hydrochloride28 in 1 BOTTLE, PLASTICCAPSULE281
52959-336-30Tetracycline Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE301
52959-336-40Tetracycline Hydrochloride40 in 1 BOTTLE, PLASTICCAPSULE401
52959-336-56Tetracycline Hydrochloride56 in 1 BOTTLE, PLASTICCAPSULE561
52959-336-90Tetracycline Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-336-14EA - Each52959-336f3b98929-95a8-44a7-90db-a6f21764ea4612013-02-13
52959-336-20EA - Each52959-33617c66c4d-5884-4db4-9139-5c732c0da71212013-02-13
52959-336-28EA - Each52959-3368a5a2afc-13e8-4645-b072-4d8dcd7a072812013-02-13
52959-336-30EA - Each52959-336a228392b-cc2c-417a-9937-f217adffa84412013-02-13
52959-336-40EA - Each52959-3366656490a-2fb5-4dc3-aedf-08d72d88467912013-02-13
52959-336-56EA - Each52959-336b4e9e955-18aa-44a0-b3a0-5230df6526ef12013-02-13
52959-336-90EA - Each52959-336b7bcedf7-2cdd-4aa7-bf57-fec8df353fcd12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TETRACYCLINE HYDROCHLORIDEACTIVE INGREDIENTP6R62377KVTETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
TETRACYCLINEACTIVE MOIETYF8VB5M810TTETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XTETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LTETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OTETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-336TETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 7 package rows20120829_54d1720d-edfc-4eb4-8388-f61bd5971336.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198252tetracycline HCl 500 MG Oral CapsulePSN54d1720d-edfc-4eb4-8388-f61bd59713361
198252tetracycline hydrochloride 500 MG Oral CapsuleSCD54d1720d-edfc-4eb4-8388-f61bd59713361
198252tetracycline (as tetracycline hydrochloride) 500 MG Oral CapsuleSY54d1720d-edfc-4eb4-8388-f61bd59713361
198252tetracycline HCl 500 MG Oral CapsuleSY54d1720d-edfc-4eb4-8388-f61bd59713361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-336-145295903361414 in 1 BOTTLE, PLASTICHistorical
52959-336-205295903362020 in 1 BOTTLE, PLASTICHistorical
52959-336-285295903362828 in 1 BOTTLE, PLASTICHistorical
52959-336-305295903363030 in 1 BOTTLE, PLASTICHistorical
52959-336-405295903364040 in 1 BOTTLE, PLASTICHistorical
52959-336-565295903365656 in 1 BOTTLE, PLASTICHistorical
52959-336-905295903369090 in 1 BOTTLE, PLASTICHistorical