Tetracycline Hydrochloride

Product NDC
0591-2474
11-digit product format
005912474
Labeler code
0591
Product ID
0591-2474_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
250 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 HYDROCHLORIDE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP6R62377KV
Rxcui198250, 198252

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-2474-01Tetracycline Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE10020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2474-01EA - Each0591-24747164c61f-106c-4e4a-bcc3-7c44a9347a1e12016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2474TETRACYCLINE 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-2474-000059124740037590 CAPSULE in 1 BOX (0591-2474-00)37590 capsule15-AUG-11Current
0591-2474-0100591247401100 CAPSULE in 1 BOTTLE, PLASTIC (0591-2474-01) 100 capsule2011-08-150000-00-00NoNoCurrent