tetracycline hydrochloride

Product NDC
23155-018
11-digit product format
231550018
Labeler code
23155
Product ID
23155-018_0d5bebf0-11ec-4572-9728-d8721296b1f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tetracycline hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
NDA050278
Marketing category
NDA
Marketing start
2024-09-15
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
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
23155-018-01tetracycline hydrochloride100 in 1 BOTTLECAPSULE10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-018-01EA - Each23155-018e9225bce-3158-4fc3-bfe8-21bd148cd11812013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TETRACYCLINE HYDROCHLORIDEACTIVE INGREDIENTP6R62377KVTETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
TETRACYCLINEACTIVE MOIETYF8VB5M810TTETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
GELATININACTIVE INGREDIENT2G86QN327LTETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPTETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OTETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-018TETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 1 package rows20250406_eaa5b1bd-0927-46e4-b941-32fcc492d258.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198250tetracycline HCl 250 MG Oral CapsulePSNeaa5b1bd-0927-46e4-b941-32fcc492d25811
198252tetracycline HCl 500 MG Oral CapsulePSNeaa5b1bd-0927-46e4-b941-32fcc492d25811
198250tetracycline hydrochloride 250 MG Oral CapsuleSCDeaa5b1bd-0927-46e4-b941-32fcc492d25811
198252tetracycline hydrochloride 500 MG Oral CapsuleSCDeaa5b1bd-0927-46e4-b941-32fcc492d25811
198252tetracycline (as tetracycline hydrochloride) 500 MG Oral CapsuleSYeaa5b1bd-0927-46e4-b941-32fcc492d25811
198252tetracycline HCl 500 MG Oral CapsuleSYeaa5b1bd-0927-46e4-b941-32fcc492d25811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-018-0123155001801100 CAPSULE in 1 BOTTLE (23155-018-01) 100 capsule2024-09-150000-00-00NoNoCurrent
23155-018-10231550018101000 CAPSULE in 1 BOTTLE (23155-018-10) 1000 capsule2013-10-180000-00-00NoNoCurrent