Tetracycline Hydrochloride

Product NDC
68788-8853
11-digit product format
687888853
Labeler code
68788
Product ID
68788-8853_4202cbfb-52e9-47f2-bd3a-1003319ca3cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tetracycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA061837
Marketing category
ANDA
Marketing start
2025-03-24
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
Rxcui198252

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
68788-8853-3Tetracycline Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8853-3EA - Each68788-88538075df0f-5838-4643-846b-ea721329dcdd12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8853TETRACYCLINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 1 package rows20250326_4202cbfb-52e9-47f2-bd3a-1003319ca3cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198252tetracycline HCl 500 MG Oral CapsulePSN4202cbfb-52e9-47f2-bd3a-1003319ca3cb1
198252tetracycline hydrochloride 500 MG Oral CapsuleSCD4202cbfb-52e9-47f2-bd3a-1003319ca3cb1
198252tetracycline (as tetracycline hydrochloride) 500 MG Oral CapsuleSY4202cbfb-52e9-47f2-bd3a-1003319ca3cb1
198252tetracycline HCl 500 MG Oral CapsuleSY4202cbfb-52e9-47f2-bd3a-1003319ca3cb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8853-36878888530330 CAPSULE in 1 BOTTLE, PLASTIC (68788-8853-3) 30 capsule2025-03-24NoNoHistorical