Tetracycline Hydrochloride

Product NDC
82644-087
11-digit product format
826440087
Labeler code
82644
Product ID
82644-087_3d44a562-4fde-4867-90e6-433ea752bb3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tetracycline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pharmaka Generics Inc.
Application
ANDA061147
Marketing category
ANDA
Marketing start
2024-01-19
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
Rxcui313252, 313254

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
82644-087-60Tetracycline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82644-087-60EA - Each82644-087760de932-7f73-4cf1-9fa7-52b712225efd12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82644-087TETRACYCLINE HYDROCHLORIDE TABLET, FILM COATED [PHARMAKA GENERICS INC.]1Current NDC, 1 package rows20240120_c522c860-84ce-4c61-ab72-077de73195df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313252tetracycline HCl 250 MG Oral TabletPSNc522c860-84ce-4c61-ab72-077de73195df1
313254tetracycline HCl 500 MG Oral TabletPSNc522c860-84ce-4c61-ab72-077de73195df1
313252tetracycline hydrochloride 250 MG Oral TabletSCDc522c860-84ce-4c61-ab72-077de73195df1
313254tetracycline hydrochloride 500 MG Oral TabletSCDc522c860-84ce-4c61-ab72-077de73195df1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82644-087-608264400876060 TABLET, FILM COATED in 1 BOTTLE (82644-087-60) 2024-01-19NoNoCurrent