Tetracycline Hydrochloride

Product NDC
69238-1523
11-digit product format
692381523
Labeler code
69238
Product ID
69238-1523_15697aca-7bc8-4a3a-a935-1b79790a919e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tetracycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA210674
Marketing category
ANDA
Marketing start
2018-09-21
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
69238-1523-1Tetracycline Hydrochloride100 in 1 BOTTLECAPSULE10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1523-1EA - Each69238-15231173a3db-8692-4851-86e1-a4dafc12ff2512019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1523TETRACYCLINE HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]12Current NDC, Legacy NDC, 1 package rows20250516_ae29aa18-6efb-47c9-bbd7-cbe8af1b7f38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198250tetracycline HCl 250 MG Oral CapsulePSNae29aa18-6efb-47c9-bbd7-cbe8af1b7f3812
198252tetracycline HCl 500 MG Oral CapsulePSNae29aa18-6efb-47c9-bbd7-cbe8af1b7f3812
198250tetracycline hydrochloride 250 MG Oral CapsuleSCDae29aa18-6efb-47c9-bbd7-cbe8af1b7f3812
198252tetracycline hydrochloride 500 MG Oral CapsuleSCDae29aa18-6efb-47c9-bbd7-cbe8af1b7f3812
198252tetracycline (as tetracycline hydrochloride) 500 MG Oral CapsuleSYae29aa18-6efb-47c9-bbd7-cbe8af1b7f3812
198252tetracycline HCl 500 MG Oral CapsuleSYae29aa18-6efb-47c9-bbd7-cbe8af1b7f3812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1523-169238152301100 CAPSULE in 1 BOTTLE (69238-1523-1) 100 capsule2018-09-210000-00-00NoNoCurrent