FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
71335-1237
11-digit product format
713351237
Labeler code
71335
Product ID
71335-1237_75bd1b9e-6824-41dc-bddb-1affc5d4e4b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA065470
Marketing category
ANDA
Marketing start
2008-03-11
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Decreased Prothrombin Activity [PE], Tetracycline-class Drug [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
Minocycline Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOCYCLINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0020414E5U
Rxcui197985

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9c90ddb-dcc8-42af-a94b-505e4488bdc7Product name120250623
9e423e97-a6d9-7bb0-0dcb-343af7c0ff92Product name220230322
472a6924-c7ed-850b-32ce-a510e887fbf9Product name420230207
f1239550-2d2e-44c3-aec7-14fd9b4ab55dProduct name120201103
7a57513a-a145-4b95-9165-1e0ef21d6017Product name120200326
70555e58-6951-4421-9354-f80c6ce0d92cProduct name720200204
23de08d7-aa4e-ec8b-ce6d-2124a855e4efProduct name520180605
76736e48-254d-4a39-993d-206efbdaad1dProduct name120170717
0c498039-5512-d9d7-e6b6-833de47219ffProduct name220151106

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1237-12024-10-23C16284748780-11030e365-6dfc-111a-e063-dadaa90a10e2Minocycline Hydrochloride Capsules, USP Rx only
71335-1237-22024-10-23C16284748780-11030e365-6dfc-111a-e063-dadaa90a10e2Minocycline Hydrochloride Capsules, USP Rx only
71335-1237-32024-10-23C16284748780-11030e365-6dfc-111a-e063-dadaa90a10e2Minocycline Hydrochloride Capsules, USP Rx only
71335-1237-42024-10-23C16284748780-11030e365-6dfc-111a-e063-dadaa90a10e2Minocycline Hydrochloride Capsules, USP Rx only
71335-1237-52024-10-23C16284748780-11030e365-6dfc-111a-e063-dadaa90a10e2Minocycline Hydrochloride Capsules, USP Rx only
71335-1237-12024-01-30C16284748780-11030e365-6dfc-111a-e063-dadaa90a10e2Minocycline Hydrochloride Capsules, USP Rx only
71335-1237-22024-01-30C16284748780-11030e365-6dfc-111a-e063-dadaa90a10e2Minocycline Hydrochloride Capsules, USP Rx only
71335-1237-32024-01-30C16284748780-11030e365-6dfc-111a-e063-dadaa90a10e2Minocycline Hydrochloride Capsules, USP Rx only
71335-1237-42024-01-30C16284748780-11030e365-6dfc-111a-e063-dadaa90a10e2Minocycline Hydrochloride Capsules, USP Rx only
71335-1237-52024-01-30C16284748780-11030e365-6dfc-111a-e063-dadaa90a10e2Minocycline Hydrochloride Capsules, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1237-1Minocycline Hydrochloride90 in 1 BOTTLECAPSULE90102
71335-1237-2Minocycline Hydrochloride50 in 1 BOTTLECAPSULE50102
71335-1237-3Minocycline Hydrochloride60 in 1 BOTTLECAPSULE60102
71335-1237-4Minocycline Hydrochloride30 in 1 BOTTLECAPSULE30102
71335-1237-5Minocycline Hydrochloride100 in 1 BOTTLECAPSULE100102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1237MINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20241025_a6224eeb-25be-4f1d-889f-809aaf338c8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197985minocycline HCl 50 MG Oral CapsulePSNa6224eeb-25be-4f1d-889f-809aaf338c8c102
197985minocycline 50 MG Oral CapsuleSCDa6224eeb-25be-4f1d-889f-809aaf338c8c102
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSYa6224eeb-25be-4f1d-889f-809aaf338c8c102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1237-17133512370190 CAPSULE in 1 BOTTLE (71335-1237-1) 90 capsule2024-10-070000-00-00NoNoCurrent
71335-1237-27133512370250 CAPSULE in 1 BOTTLE (71335-1237-2) 50 capsule2024-10-070000-00-00NoNoCurrent
71335-1237-37133512370360 CAPSULE in 1 BOTTLE (71335-1237-3) 60 capsule2019-10-300000-00-00NoNoCurrent
71335-1237-47133512370430 CAPSULE in 1 BOTTLE (71335-1237-4) 30 capsule2020-08-050000-00-00NoNoCurrent
71335-1237-571335123705100 CAPSULE in 1 BOTTLE (71335-1237-5) 100 capsule2024-10-070000-00-00NoNoCurrent