FDA.reportPublic FDA data

Tetracycline Hydrochloride

Product NDC
71335-2141
11-digit product format
713352141
Labeler code
71335
Product ID
71335-2141_dbd18052-a245-4b01-8654-0505c06cfb26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tetracycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210662
Marketing category
ANDA
Marketing start
2019-01-18
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
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
151122cd-8b80-4972-8b02-3a4dda642fbcProduct name220200701
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2141-1Tetracycline Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE60103
71335-2141-2Tetracycline Hydrochloride40 in 1 BOTTLE, PLASTICCAPSULE40103
71335-2141-3Tetracycline Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE30103
71335-2141-4Tetracycline Hydrochloride56 in 1 BOTTLE, PLASTICCAPSULE56103
71335-2141-5Tetracycline Hydrochloride28 in 1 BOTTLE, PLASTICCAPSULE28103
71335-2141-6Tetracycline Hydrochloride20 in 1 BOTTLE, PLASTICCAPSULE20103
71335-2141-7Tetracycline Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE90103
71335-2141-8Tetracycline Hydrochloride45 in 1 BOTTLE, PLASTICCAPSULE45103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2141TETRACYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 8 package rows20240420_2c9208db-5f4f-4382-854f-6786b1e458db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198252tetracycline HCl 500 MG Oral CapsulePSN2c9208db-5f4f-4382-854f-6786b1e458db103
198252tetracycline hydrochloride 500 MG Oral CapsuleSCD2c9208db-5f4f-4382-854f-6786b1e458db103
198252tetracycline (as tetracycline hydrochloride) 500 MG Oral CapsuleSY2c9208db-5f4f-4382-854f-6786b1e458db103
198252tetracycline HCl 500 MG Oral CapsuleSY2c9208db-5f4f-4382-854f-6786b1e458db103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2141-17133521410160 CAPSULE in 1 BOTTLE, PLASTIC (71335-2141-1) 60 capsule2024-04-030000-00-00NoNoCurrent
71335-2141-27133521410240 CAPSULE in 1 BOTTLE, PLASTIC (71335-2141-2) 40 capsule2024-04-030000-00-00NoNoCurrent
71335-2141-37133521410330 CAPSULE in 1 BOTTLE, PLASTIC (71335-2141-3) 30 capsule2022-07-290000-00-00NoNoCurrent
71335-2141-47133521410456 CAPSULE in 1 BOTTLE, PLASTIC (71335-2141-4) 56 capsule2024-04-030000-00-00NoNoCurrent
71335-2141-57133521410528 CAPSULE in 1 BOTTLE, PLASTIC (71335-2141-5) 28 capsule2024-04-030000-00-00NoNoCurrent
71335-2141-67133521410620 CAPSULE in 1 BOTTLE, PLASTIC (71335-2141-6) 20 capsule2024-04-030000-00-00NoNoCurrent
71335-2141-77133521410790 CAPSULE in 1 BOTTLE, PLASTIC (71335-2141-7) 90 capsule2024-04-030000-00-00NoNoCurrent
71335-2141-87133521410845 CAPSULE in 1 BOTTLE, PLASTIC (71335-2141-8) 45 capsule2024-04-030000-00-00NoNoCurrent