FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
43063-736
11-digit product format
430630736
Labeler code
43063
Product ID
43063-736_51b57b3d-2319-ef81-e063-6294a90a77d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA065062
Marketing category
ANDA
Marketing start
2015-04-02
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Minocycline Hydrochloride
Listing expiration
2027-12-31

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
43063-736-14Minocycline Hydrochloride14 in 1 BOTTLE, PLASTICCAPSULE1427
43063-736-20Minocycline Hydrochloride20 in 1 BOTTLE, PLASTICCAPSULE2027
43063-736-30Minocycline Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE3027
43063-736-60Minocycline Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE6027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-736-14EA - Each43063-7361624a93f-563f-41ec-b780-f6b586d6814f12017-05-03
43063-736-20EA - Each43063-736ee2d8b6b-ab70-46d3-8de5-6f7a2b2427ab12017-03-06
43063-736-30EA - Each43063-736bc329d05-9cdc-447d-9196-8ee6b252081912017-04-05
43063-736-60EA - Each43063-7365ea3c7bf-3525-48a0-b57e-38e79f79f5e412019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-736MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]25Current NDC, Legacy NDC, 4 package rows20240926_7e2390b7-242c-43ff-afb3-b0a5e79351d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSN7e2390b7-242c-43ff-afb3-b0a5e79351d327
197984minocycline 100 MG Oral CapsuleSCD7e2390b7-242c-43ff-afb3-b0a5e79351d327
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY7e2390b7-242c-43ff-afb3-b0a5e79351d327

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-736-144306307361414 CAPSULE in 1 BOTTLE, PLASTIC (43063-736-14) 14 capsule2017-04-040000-00-00NoNoCurrent
43063-736-204306307362020 CAPSULE in 1 BOTTLE, PLASTIC (43063-736-20) 20 capsule2017-01-230000-00-00NoNoCurrent
43063-736-304306307363030 CAPSULE in 1 BOTTLE, PLASTIC (43063-736-30) 30 capsule2017-02-030000-00-00NoNoCurrent
43063-736-604306307366060 CAPSULE in 1 BOTTLE, PLASTIC (43063-736-60) 60 capsule2017-02-030000-00-00NoNoCurrent