FDA.reportPublic FDA data

Tetracycline Hydrochloride

Product NDC
23155-767
11-digit product format
231550767
Labeler code
23155
Product ID
23155-767_8e073e02-ee9f-402e-894f-97b2c0b4dfef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tetracycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA062752
Marketing category
ANDA
Marketing start
2020-04-01
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
23155-767-01Tetracycline Hydrochloride100 in 1 BOTTLECAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-767-01EA - Each23155-76742f4dc38-4668-4755-9824-89badd45770112020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-767TETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 1 package rows20230707_3ce3e8dc-7fbd-4f8d-a65f-092e1ef21725.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198252tetracycline HCl 500 MG Oral CapsulePSN22208459-3e6f-46a7-9f7f-f2c254a38132101
198252tetracycline hydrochloride 500 MG Oral CapsuleSCD22208459-3e6f-46a7-9f7f-f2c254a38132101
198252tetracycline (as tetracycline hydrochloride) 500 MG Oral CapsuleSY22208459-3e6f-46a7-9f7f-f2c254a38132101
198252tetracycline HCl 500 MG Oral CapsuleSY22208459-3e6f-46a7-9f7f-f2c254a38132101
198250tetracycline HCl 250 MG Oral CapsulePSN3ce3e8dc-7fbd-4f8d-a65f-092e1ef217253
198252tetracycline HCl 500 MG Oral CapsulePSN3ce3e8dc-7fbd-4f8d-a65f-092e1ef217253
198250tetracycline hydrochloride 250 MG Oral CapsuleSCD3ce3e8dc-7fbd-4f8d-a65f-092e1ef217253
198252tetracycline hydrochloride 500 MG Oral CapsuleSCD3ce3e8dc-7fbd-4f8d-a65f-092e1ef217253
198252tetracycline (as tetracycline hydrochloride) 500 MG Oral CapsuleSY3ce3e8dc-7fbd-4f8d-a65f-092e1ef217253
198252tetracycline HCl 500 MG Oral CapsuleSY3ce3e8dc-7fbd-4f8d-a65f-092e1ef217253
198252tetracycline HCl 500 MG Oral CapsulePSNd48071a0-c397-42f8-b8ad-158282e745e31
198252tetracycline hydrochloride 500 MG Oral CapsuleSCDd48071a0-c397-42f8-b8ad-158282e745e31
198252tetracycline (as tetracycline hydrochloride) 500 MG Oral CapsuleSYd48071a0-c397-42f8-b8ad-158282e745e31
198252tetracycline HCl 500 MG Oral CapsuleSYd48071a0-c397-42f8-b8ad-158282e745e31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-767-0123155076701100 CAPSULE in 1 BOTTLE (23155-767-01) 100 capsule2020-04-010000-00-00NoNoCurrent