FDA.reportPublic FDA data

Tetracyte Topical Tetracycline Hydrochloride

Product NDC
71262-009
11-digit product format
712620009
Labeler code
71262
Product ID
71262-009_1ea3306d-037f-cb46-e063-6294a90abc20
Type
HUMAN OTC DRUG
Nonproprietary name
TETRACYCLINE HYDROCHLORIDE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
VIADERMA DISTRIBUTION INC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-01
Substance
TETRACYCLINE HYDROCHLORIDE
Active strength
30 mg/mL
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
Tetracyte Topical Tetracycline Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRACYCLINE HYDROCHLORIDE30 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP6R62377KV
Rxcui1542813

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
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71262-009-01Tetracyte Topical Tetracycline Hydrochloride1 in 1 CARTONOINTMENT13
71262-009-01Tetracyte Topical Tetracycline Hydrochloride15 mL in 1 BOTTLEOINTMENT153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71262-009TETRACYTE TOPICAL TETRACYCLINE HYDROCHLORIDE (TETRACYCLINE HYDROCHLORIDE) OINTMENT [VIADERMA DISTRIBUTION INC]3Current NDC, 2 package rows20240802_4ac5177d-bb67-45e6-adcf-44f0821746bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1542813tetracycline HCl 3 % Topical OintmentPSN4ac5177d-bb67-45e6-adcf-44f0821746bd3
1542813tetracycline hydrochloride 0.03 MG/MG Topical OintmentSCD4ac5177d-bb67-45e6-adcf-44f0821746bd3
1542813tetracycline HCl 3 % Topical OintmentSY4ac5177d-bb67-45e6-adcf-44f0821746bd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71262-009-01712620009011 BOTTLE in 1 CARTON (71262-009-01) / 15 mL in 1 BOTTLE1 bottle2024-05-01NoNoHistorical