Solodyn

Product NDC
99207-466
11-digit product format
992070466
Labeler code
99207
Product ID
99207-466_a594be33-33ce-4304-a6fe-65a4eeda3f19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
minocycline hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bausch Health US LLC
Application
NDA050808
Marketing category
NDA
Marketing start
2010-09-27
Marketing end
0000-00-00
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
80 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
23de08d7-aa4e-ec8b-ce6d-2124a855e4efProduct name520180605
76736e48-254d-4a39-993d-206efbdaad1dProduct name120170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
0c498039-5512-d9d7-e6b6-833de47219ffProduct name220151106
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
99207-466-30EA - Each99207-466ab4d9310-637b-4e15-aeb6-25edc737580c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
minocycline hydrochlorideACTIVE INGREDIENT0020414E5USOLODYN (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
minocyclineACTIVE MOIETYFYY3R43WGOSOLODYN (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKSOLODYN (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOASOLODYN (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8SOLODYN (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
hypromellose 2910 (50 mpa.s)INACTIVE INGREDIENT1IVH67816NSOLODYN (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XSOLODYN (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PSOLODYN (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSOLODYN (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
triacetinINACTIVE INGREDIENTXHX3C3X673SOLODYN (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1013665minocycline HCl 80 MG 24HR Extended Release Oral TabletPSN6ade9be7-f10f-40b2-b5c5-39c5aef3a83d1
1014024SOLODYN 80 MG 24HR Extended Release Oral TabletPSN6ade9be7-f10f-40b2-b5c5-39c5aef3a83d1
101402424 HR minocycline 80 MG Extended Release Oral Tablet [Solodyn]SBD6ade9be7-f10f-40b2-b5c5-39c5aef3a83d1
101366524 HR minocycline 80 MG Extended Release Oral TabletSCD6ade9be7-f10f-40b2-b5c5-39c5aef3a83d1
101402424 HR Solodyn 80 MG Extended Release Oral TabletSY6ade9be7-f10f-40b2-b5c5-39c5aef3a83d1
1013665minocycline 80 MG 24 HR Extended Release Oral TabletSY6ade9be7-f10f-40b2-b5c5-39c5aef3a83d1
1014024Solodyn (minocycline hydrochloride) 80 MG 24 HR Extended Release Oral TabletSY6ade9be7-f10f-40b2-b5c5-39c5aef3a83d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
99207-466-029920704660210 BOTTLE in 1 CARTON (99207-466-02) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE10 bottle2010-09-270000-00-00NoNoCurrent
99207-466-309920704663030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (99207-466-30) 2010-09-270000-00-00NoNoCurrent