FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
71205-511
11-digit product format
712050511
Labeler code
71205
Product ID
71205-511_d03fd8ae-453f-4b31-b05a-d068f238c8a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090867
Marketing category
ANDA
Marketing start
2013-05-13
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
71205-511-30Minocycline Hydrochloride30 in 1 BOTTLECAPSULE302
71205-511-60Minocycline Hydrochloride60 in 1 BOTTLECAPSULE602
71205-511-90Minocycline Hydrochloride90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-511MINOCYCLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20230520_49e65b60-ffc9-4ccd-9aec-29a462358d27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSN49e65b60-ffc9-4ccd-9aec-29a462358d272
197984minocycline 100 MG Oral CapsuleSCD49e65b60-ffc9-4ccd-9aec-29a462358d272
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY49e65b60-ffc9-4ccd-9aec-29a462358d272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-511-307120505113030 CAPSULE in 1 BOTTLE (71205-511-30) 30 capsule2020-12-030000-00-00NoNoCurrent
71205-511-607120505116060 CAPSULE in 1 BOTTLE (71205-511-60) 60 capsule2020-12-030000-00-00NoNoCurrent
71205-511-907120505119090 CAPSULE in 1 BOTTLE (71205-511-90) 90 capsule2020-12-030000-00-00NoNoCurrent