FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
71205-272
11-digit product format
712050272
Labeler code
71205
Product ID
71205-272_716c5abe-6d0e-4cfd-9c37-45a967e136ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065470
Marketing category
ANDA
Marketing start
2008-03-11
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
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
71205-272-20Minocycline Hydrochloride20 in 1 BOTTLECAPSULE204
71205-272-21Minocycline Hydrochloride21 in 1 BOTTLECAPSULE214
71205-272-30Minocycline Hydrochloride30 in 1 BOTTLECAPSULE304
71205-272-60Minocycline Hydrochloride60 in 1 BOTTLECAPSULE604
71205-272-90Minocycline Hydrochloride90 in 1 BOTTLECAPSULE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-272MINOCYCLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 5 package rows20230528_4f904969-5af3-461e-b557-d03a1e5c7292.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSN4f904969-5af3-461e-b557-d03a1e5c72924
197984minocycline 100 MG Oral CapsuleSCD4f904969-5af3-461e-b557-d03a1e5c72924
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY4f904969-5af3-461e-b557-d03a1e5c72924

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-272-207120502722020 CAPSULE in 1 BOTTLE (71205-272-20) 20 capsule2019-05-010000-00-00NoNoCurrent
71205-272-217120502722121 CAPSULE in 1 BOTTLE (71205-272-21) 21 capsule2019-05-010000-00-00NoNoCurrent
71205-272-307120502723030 CAPSULE in 1 BOTTLE (71205-272-30) 30 capsule2019-05-010000-00-00NoNoCurrent
71205-272-607120502726060 CAPSULE in 1 BOTTLE (71205-272-60) 60 capsule2019-05-010000-00-00NoNoCurrent
71205-272-907120502729090 CAPSULE in 1 BOTTLE (71205-272-90) 90 capsule2019-05-010000-00-00NoNoCurrent