FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
63187-850
11-digit product format
631870850
Labeler code
63187
Product ID
63187-850_6606118e-4e3d-4559-9cd9-3894c3147260
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065062
Marketing category
ANDA
Marketing start
2015-04-02
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

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
63187-850-20Minocycline Hydrochloride20 in 1 BOTTLECAPSULE203
63187-850-21Minocycline Hydrochloride21 in 1 BOTTLECAPSULE213
63187-850-30Minocycline Hydrochloride30 in 1 BOTTLECAPSULE303
63187-850-60Minocycline Hydrochloride60 in 1 BOTTLECAPSULE603
63187-850-90Minocycline Hydrochloride90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-850-21EA - Each63187-85059b70385-7ef0-4cea-a0b1-0c3b1447dab812017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-850MINOCYCLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 5 package rows20191113_d67e4b17-7d44-4d72-9150-420d98cc6db3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSNd67e4b17-7d44-4d72-9150-420d98cc6db33
197984minocycline 100 MG Oral CapsuleSCDd67e4b17-7d44-4d72-9150-420d98cc6db33
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYd67e4b17-7d44-4d72-9150-420d98cc6db33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-850-206318708502020 CAPSULE in 1 BOTTLE (63187-850-20) 20 capsule2017-05-010000-00-00NoNoCurrent
63187-850-216318708502121 CAPSULE in 1 BOTTLE (63187-850-21) 21 capsule2017-05-010000-00-00NoNoCurrent
63187-850-306318708503030 CAPSULE in 1 BOTTLE (63187-850-30) 30 capsule2017-05-010000-00-00NoNoCurrent
63187-850-606318708506060 CAPSULE in 1 BOTTLE (63187-850-60) 60 capsule2017-05-010000-00-00NoNoCurrent
63187-850-906318708509090 CAPSULE in 1 BOTTLE (63187-850-90) 90 capsule2017-05-010000-00-00NoNoCurrent