FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
80425-0390
11-digit product format
804250390
Labeler code
80425
Product ID
80425-0390_19233bc0-9973-2002-e063-6394a90a057c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA065470
Marketing category
ANDA
Marketing start
2024-05-23
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0020414E5U
Rxcui197984

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9c90ddb-dcc8-42af-a94b-505e4488bdc7Product name120250623
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0390-1Minocycline Hydrochloride30 in 1 BOTTLECAPSULE301
80425-0390-2Minocycline Hydrochloride60 in 1 BOTTLECAPSULE601
80425-0390-3Minocycline Hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0390-1EA - Each80425-039071fe8381-bc34-4a90-9350-e4076beeac5c12024-07-12
80425-0390-2EA - Each80425-03908a72d2c2-2243-4847-91a9-9faaf4e71be812024-07-12
80425-0390-3EA - Each80425-0390d4022afc-f65f-42d3-b4a7-3080266a1d2212024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0390MINOCYCLINE HYDROCHLORIDE CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]1Current NDC, 3 package rows20240601_192327c5-d2bc-1bd1-e063-6394a90a110b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSN192327c5-d2bc-1bd1-e063-6394a90a110b1
197984minocycline 100 MG Oral CapsuleSCD192327c5-d2bc-1bd1-e063-6394a90a110b1
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY192327c5-d2bc-1bd1-e063-6394a90a110b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0390-18042503900130 CAPSULE in 1 BOTTLE (80425-0390-1) 30 capsule2024-05-23NoNoHistorical
80425-0390-28042503900260 CAPSULE in 1 BOTTLE (80425-0390-2) 60 capsule2024-05-23NoNoHistorical
80425-0390-38042503900390 CAPSULE in 1 BOTTLE (80425-0390-3) 90 capsule2024-05-23NoNoHistorical