Tetracycline Hydrochloride

Product NDC
62135-225
11-digit product format
621350225
Labeler code
62135
Product ID
62135-225_00d7f688-41b8-3498-e063-6394a90a8a3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tetracycline hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Chartwell RX, LLC.
Application
ANDA062752
Marketing category
ANDA
Marketing start
1988-08-12
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
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
62135-225-01Tetracycline Hydrochloride100 in 1 BOTTLECAPSULE1007
62135-225-05Tetracycline Hydrochloride500 in 1 BOTTLECAPSULE5007
62135-225-20Tetracycline Hydrochloride20 in 1 BOTTLECAPSULE207
62135-225-60Tetracycline Hydrochloride60 in 1 BOTTLECAPSULE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-225-01EA - Each62135-225e6a2f559-ccb7-421c-b969-2af48fa1cc6112020-04-20
62135-225-60EA - Each62135-225137b1543-8fc9-4a8f-a325-8582380a583512021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-225TETRACYCLINE HYDROCHLORIDE CAPSULE [CHARTWELL RX, LLC.]7Current NDC, Legacy NDC, 4 package rows20230720_aa30113f-ab58-4f41-82c1-2fcb540d4a82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198250tetracycline HCl 250 MG Oral CapsulePSNaa30113f-ab58-4f41-82c1-2fcb540d4a827
198252tetracycline HCl 500 MG Oral CapsulePSNaa30113f-ab58-4f41-82c1-2fcb540d4a827
198250tetracycline hydrochloride 250 MG Oral CapsuleSCDaa30113f-ab58-4f41-82c1-2fcb540d4a827
198252tetracycline hydrochloride 500 MG Oral CapsuleSCDaa30113f-ab58-4f41-82c1-2fcb540d4a827
198252tetracycline (as tetracycline hydrochloride) 500 MG Oral CapsuleSYaa30113f-ab58-4f41-82c1-2fcb540d4a827
198252tetracycline HCl 500 MG Oral CapsuleSYaa30113f-ab58-4f41-82c1-2fcb540d4a827

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-225-0162135022501100 CAPSULE in 1 BOTTLE (62135-225-01) 100 capsule2020-03-010000-00-00NoNoCurrent
62135-225-0562135022505500 CAPSULE in 1 BOTTLE (62135-225-05) 500 capsule2020-03-010000-00-00NoNoCurrent
62135-225-206213502252020 CAPSULE in 1 BOTTLE (62135-225-20) 20 capsule2020-03-010000-00-00NoNoCurrent
62135-225-606213502256060 CAPSULE in 1 BOTTLE (62135-225-60) 60 capsule2021-03-010000-00-00NoNoCurrent