FDA.reportPublic FDA data

minocycline hydrochloride

Product NDC
50090-3697
11-digit product format
500903697
Labeler code
50090
Product ID
50090-3697_a36cbf9c-3798-41c2-8281-de05c608ab8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
minocycline hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA063067
Marketing category
ANDA
Marketing start
2017-10-31
Marketing end
0000-00-00
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3697-02023-01-30C16284748780-1f386c649-caee-0266-e053-dadaa90a7c1aMINOCYCLINE HYDROCHLORIDE CAPSULES, USP
50090-3697-22023-01-30C16284748780-1f386c649-caee-0266-e053-dadaa90a7c1aMINOCYCLINE HYDROCHLORIDE CAPSULES, USP
50090-3697-32023-01-30C16284748780-1f386c649-caee-0266-e053-dadaa90a7c1aMINOCYCLINE HYDROCHLORIDE CAPSULES, USP
50090-3697-42023-01-30C16284748780-1f386c649-caee-0266-e053-dadaa90a7c1aMINOCYCLINE HYDROCHLORIDE CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3697-0minocycline hydrochloride60 in 1 BOTTLECAPSULE608
50090-3697-2minocycline hydrochloride20 in 1 BOTTLECAPSULE208
50090-3697-3minocycline hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE308
50090-3697-4minocycline hydrochloride90 in 1 BOTTLECAPSULE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3697-0EA - Each50090-36970c2581ba-9ff7-457c-bb0f-fdfcb36bde0e12021-11-09
50090-3697-2EA - Each50090-3697a16fd2d8-9330-4212-982b-92a23602327e12021-11-09
50090-3697-3EA - Each50090-3697d4cca1d7-e13c-4f0e-a4d6-17da4dec4c8e12021-08-05
50090-3697-4EA - Each50090-36975be90c50-a5e1-43a1-bfe4-4c531d778a4612021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3697MINOCYCLINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]8Legacy NDC, 4 package rows20210303_7bc2214a-5b2c-4e69-8c90-028b8eea230c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSN7bc2214a-5b2c-4e69-8c90-028b8eea230c8
197984minocycline 100 MG Oral CapsuleSCD7bc2214a-5b2c-4e69-8c90-028b8eea230c8
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY7bc2214a-5b2c-4e69-8c90-028b8eea230c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3697-05009036970060 CAPSULE in 1 BOTTLE (50090-3697-0) 60 capsule2018-10-190000-00-00NoNoCurrent
50090-3697-25009036970220 CAPSULE in 1 BOTTLE (50090-3697-2) 20 capsule2018-10-190000-00-00NoNoCurrent
50090-3697-35009036970330 CAPSULE in 1 BOTTLE, PLASTIC (50090-3697-3) 30 capsule2017-10-310000-00-00NoNoCurrent
50090-3697-45009036970490 CAPSULE in 1 BOTTLE (50090-3697-4) 90 capsule2018-10-190000-00-00NoNoCurrent