FDA.reportPublic FDA data

Metadate CD

Product NDC
53014-580
11-digit product format
530140580
Labeler code
53014
Product ID
53014-580_bb9a02a4-3803-482d-970d-0f27f3b6f452
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylphenidate hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Unither Manufacturing, LLC
Application
NDA021259
Marketing category
NDA
Marketing start
2003-02-18
Marketing end
0000-00-00
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
143536be-f21a-464c-bc5a-163f5c171815Product name220250626
fd4d0878-dcea-3832-288e-e3bbbbe580ffProduct name920240516
435f0341-cf24-41d5-8fbf-c909821e5596Product name120230313
c9b6eabb-08d7-bb2d-e81a-06be3590b436Product name220221216
67aa32c6-44f4-50de-64dd-643e8caf420dProduct name620210622
50b24f34-96fa-4f1e-b262-b0baf4a4a440Product name420210513
cf83c421-eebe-4de2-b1a2-fd96e3dbfcf8Product name120200128
166d1d2d-dd55-4fdf-82e2-b83a3c5347c1Product name120190828
343a61d5-785d-cc27-a43a-0779da054d88Product name320190828
7607489b-cd15-3103-f3b1-d4283574d250Product name220190614
407f0cce-da29-4050-a512-2cabe9e5692dProduct name920190611
f7f4bf1e-7c67-46c6-8c42-9beb1a06b38eProduct name220190415
190572d9-6c7b-4b40-8172-c1b5f802c20fProduct name120180724
2948856e-f76e-d380-d9ed-b317efafbc98Product name520180423
c0aa09de-7aa1-4a98-8f70-62ec3c97c695Product name120170803
3317aade-2d6e-f159-9fe6-e8385a825178Product name320160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3Product name120160111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53014-580-07EA - Each53014-580cbd683fc-70b1-42f9-ae3f-d2e183838edd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT4B3SC438HIMETADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
METHYLPHENIDATEACTIVE MOIETY207ZZ9QZ49METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYMETADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BMETADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMETADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMETADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LMETADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AMETADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091139Metadate CD 10 MG 24HR Extended Release Oral CapsulePSNbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
1091163Metadate CD 20 MG 24HR Extended Release Oral CapsulePSNbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
1091178Metadate CD 30 MG 24HR Extended Release Oral CapsulePSNbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
1091204Metadate CD 50 MG 24HR Extended Release Oral CapsulePSNbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
1806181methylphenidate HCl 10 MG 30/70 Release 24HR Extended Release Oral CapsulePSNbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
1806187methylphenidate HCl 20 MG 30/70 Release 24HR Extended Release Oral CapsulePSNbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
1806189methylphenidate HCl 30 MG 30/70 Release 24HR Extended Release Oral CapsulePSNbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
1806193methylphenidate HCl 50 MG 30/70 Release 24HR Extended Release Oral CapsulePSNbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
109113930/70 Release 24 HR methylphenidate hydrochloride 10 MG Extended Release Oral Capsule [Metadate]SBDbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
109116330/70 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral Capsule [Metadate]SBDbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
109117830/70 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral Capsule [Metadate]SBDbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
109120430/70 Release 24 HR methylphenidate hydrochloride 50 MG Extended Release Oral Capsule [Metadate]SBDbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
180618130/70 Release 24 HR methylphenidate hydrochloride 10 MG Extended Release Oral CapsuleSCDbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
180618730/70 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral CapsuleSCDbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
180618930/70 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral CapsuleSCDbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
180619330/70 Release 24 HR methylphenidate hydrochloride 50 MG Extended Release Oral CapsuleSCDbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
1091139Metadate CD 10 MG 24 HR Extended Release Oral CapsuleSYbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
1091163Metadate CD 20 MG 24HR Extended Release Oral CapsuleSYbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
1091178Metadate CD 30 MG 24HR Extended Release Oral CapsuleSYbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
1091204Metadate CD 50 MG 24HR Extended Release Oral CapsuleSYbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
1806181methylphenidate HCl 10 MG 30/70 Release 24HR Extended Release Oral CapsuleSYbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
1806187methylphenidate HCl 20 MG 30/70 Release 24HR Extended Release Oral CapsuleSYbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
1806189methylphenidate HCl 30 MG 30/70 Release 24HR Extended Release Oral CapsuleSYbe6f8d00-9281-4f67-b8fc-3de58a4d14f41
1806193methylphenidate HCl 50 MG 30/70 Release 24HR Extended Release Oral CapsuleSYbe6f8d00-9281-4f67-b8fc-3de58a4d14f41