Minocycline hydrochloride

Product NDC
63187-036
11-digit product format
631870036
Labeler code
63187
Product ID
63187-036_cf41df26-cc0b-4e51-a3dc-f3c8ea186150
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065062
Marketing category
ANDA
Marketing start
2000-12-22
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
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, 197985

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
63187-036-20Minocycline hydrochloride20 in 1 BOTTLECAPSULE205
63187-036-21Minocycline hydrochloride21 in 1 BOTTLECAPSULE215
63187-036-30Minocycline hydrochloride30 in 1 BOTTLECAPSULE305
63187-036-60Minocycline hydrochloride60 in 1 BOTTLECAPSULE605
63187-036-90Minocycline hydrochloride90 in 1 BOTTLECAPSULE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-036MINOCYCLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 5 package rows20210115_e6b04358-0f4c-4b21-a7f3-320d1e7bc0b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSNe6b04358-0f4c-4b21-a7f3-320d1e7bc0b85
197985minocycline HCl 50 MG Oral CapsulePSNe6b04358-0f4c-4b21-a7f3-320d1e7bc0b85
197984minocycline 100 MG Oral CapsuleSCDe6b04358-0f4c-4b21-a7f3-320d1e7bc0b85
197985minocycline 50 MG Oral CapsuleSCDe6b04358-0f4c-4b21-a7f3-320d1e7bc0b85
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYe6b04358-0f4c-4b21-a7f3-320d1e7bc0b85
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSYe6b04358-0f4c-4b21-a7f3-320d1e7bc0b85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-036-206318700362020 CAPSULE in 1 BOTTLE (63187-036-20) 20 capsule2014-04-010000-00-00NoNoCurrent
63187-036-216318700362121 CAPSULE in 1 BOTTLE (63187-036-21) 21 capsule2014-04-010000-00-00NoNoCurrent
63187-036-306318700363030 CAPSULE in 1 BOTTLE (63187-036-30) 30 capsule2014-04-010000-00-00NoNoCurrent
63187-036-606318700366060 CAPSULE in 1 BOTTLE (63187-036-60) 60 capsule2014-04-010000-00-00NoNoCurrent
63187-036-906318700369090 CAPSULE in 1 BOTTLE (63187-036-90) 90 capsule2014-04-010000-00-00NoNoCurrent