FDA.reportPublic FDA data

Tetracycline Hydrochloride

Product NDC
51991-907
11-digit product format
519910907
Labeler code
51991
Product ID
51991-907_a8cfae79-912a-40ad-99b3-02510f5b7bed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tetracycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRACYCLINE HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP6R62377KV

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
151122cd-8b80-4972-8b02-3a4dda642fbcProduct name220200701
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51991-907-01Tetracycline Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE1008
51991-907-05Tetracycline Hydrochloride500 in 1 BOTTLE, PLASTICCAPSULE5008
51991-907-33Tetracycline Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-907-01EA - Each51991-907307a8f99-9f9f-4cfc-96ac-beb2ab74bc9c12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-907TETRACYCLINE HYDROCHLORIDE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]7Current NDC, Legacy NDC, 3 package rows20240327_00acf413-c5d2-4a54-9d0d-56266cbc9edc.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
198250tetracycline HCl 250 MG Oral CapsulePSN00acf413-c5d2-4a54-9d0d-56266cbc9edc8
198252tetracycline HCl 500 MG Oral CapsulePSN00acf413-c5d2-4a54-9d0d-56266cbc9edc8
198250tetracycline hydrochloride 250 MG Oral CapsuleSCD00acf413-c5d2-4a54-9d0d-56266cbc9edc8
198252tetracycline hydrochloride 500 MG Oral CapsuleSCD00acf413-c5d2-4a54-9d0d-56266cbc9edc8
198252tetracycline (as tetracycline hydrochloride) 500 MG Oral CapsuleSY00acf413-c5d2-4a54-9d0d-56266cbc9edc8
198252tetracycline HCl 500 MG Oral CapsuleSY00acf413-c5d2-4a54-9d0d-56266cbc9edc8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51991-907-0151991090701100 CAPSULE in 1 BOTTLE, PLASTIC (51991-907-01) 100 capsule2019-01-180000-00-00NoNoCurrent
51991-907-0551991090705500 CAPSULE in 1 BOTTLE, PLASTIC (51991-907-05) 500 capsule2019-01-180000-00-00NoNoCurrent
51991-907-335199109073330 CAPSULE in 1 BOTTLE, PLASTIC (51991-907-33) 30 capsule2019-01-180000-00-00NoNoCurrent