FDA.reportPublic FDA data

METADATE CD

Product NDC
69654-582
11-digit product format
696540582
Labeler code
69654
Product ID
69654-582_43e0b75f-01c3-28cd-e063-6394a90a74a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylphenidate hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Aytu BioPharma, Inc.
Application
NDA021259
Marketing category
NDA
Marketing start
2024-02-22
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
METADATE CD
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B3SC438HI
Rxcui1091139, 1091163, 1091178, 1091193, 1091204, 1091220, 1806181, 1806187, 1806189, 1806191, 1806193, 1806197

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69654-582-30METADATE CD30 in 1 BOTTLECAPSULE, EXTENDED RELEASE306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69654-582-30EA - Each69654-5828814270f-07f8-4420-a7cb-43c322a4098c12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69654-582METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [AYTU BIOPHARMA, INC.]4Current NDC, 1 package rows20250119_be59f8b4-7842-42cc-9559-bfa747f0baa5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091139Metadate CD 10 MG 24HR Extended Release Oral CapsulePSNbe59f8b4-7842-42cc-9559-bfa747f0baa56
1091163Metadate CD 20 MG 24HR Extended Release Oral CapsulePSNbe59f8b4-7842-42cc-9559-bfa747f0baa56
1091178Metadate CD 30 MG 24HR Extended Release Oral CapsulePSNbe59f8b4-7842-42cc-9559-bfa747f0baa56
1091193Metadate CD 40 MG 24HR Extended Release Oral CapsulePSNbe59f8b4-7842-42cc-9559-bfa747f0baa56
1091204Metadate CD 50 MG 24HR Extended Release Oral CapsulePSNbe59f8b4-7842-42cc-9559-bfa747f0baa56
1091220Metadate CD 60 MG 24HR Extended Release Oral CapsulePSNbe59f8b4-7842-42cc-9559-bfa747f0baa56
1806181methylphenidate HCl 10 MG 30/70 Release 24HR Extended Release Oral CapsulePSNbe59f8b4-7842-42cc-9559-bfa747f0baa56
1806187methylphenidate HCl 20 MG 30/70 Release 24HR Extended Release Oral CapsulePSNbe59f8b4-7842-42cc-9559-bfa747f0baa56
1806189methylphenidate HCl 30 MG 30/70 Release 24HR Extended Release Oral CapsulePSNbe59f8b4-7842-42cc-9559-bfa747f0baa56
1806191methylphenidate HCl 40 MG 30/70 Release 24HR Extended Release Oral CapsulePSNbe59f8b4-7842-42cc-9559-bfa747f0baa56
1806193methylphenidate HCl 50 MG 30/70 Release 24HR Extended Release Oral CapsulePSNbe59f8b4-7842-42cc-9559-bfa747f0baa56
1806197methylphenidate HCl 60 MG 30/70 Release 24HR Extended Release Oral CapsulePSNbe59f8b4-7842-42cc-9559-bfa747f0baa56
109113930/70 Release 24 HR methylphenidate hydrochloride 10 MG Extended Release Oral Capsule [Metadate]SBDbe59f8b4-7842-42cc-9559-bfa747f0baa56
109116330/70 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral Capsule [Metadate]SBDbe59f8b4-7842-42cc-9559-bfa747f0baa56
109117830/70 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral Capsule [Metadate]SBDbe59f8b4-7842-42cc-9559-bfa747f0baa56
109119330/70 Release 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral Capsule [Metadate]SBDbe59f8b4-7842-42cc-9559-bfa747f0baa56
109120430/70 Release 24 HR methylphenidate hydrochloride 50 MG Extended Release Oral Capsule [Metadate]SBDbe59f8b4-7842-42cc-9559-bfa747f0baa56
109122030/70 Release 24 HR methylphenidate hydrochloride 60 MG Extended Release Oral Capsule [Metadate]SBDbe59f8b4-7842-42cc-9559-bfa747f0baa56
180618130/70 Release 24 HR methylphenidate hydrochloride 10 MG Extended Release Oral CapsuleSCDbe59f8b4-7842-42cc-9559-bfa747f0baa56
180618730/70 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral CapsuleSCDbe59f8b4-7842-42cc-9559-bfa747f0baa56
180618930/70 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral CapsuleSCDbe59f8b4-7842-42cc-9559-bfa747f0baa56
180619130/70 Release 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral CapsuleSCDbe59f8b4-7842-42cc-9559-bfa747f0baa56
180619330/70 Release 24 HR methylphenidate hydrochloride 50 MG Extended Release Oral CapsuleSCDbe59f8b4-7842-42cc-9559-bfa747f0baa56
180619730/70 Release 24 HR methylphenidate hydrochloride 60 MG Extended Release Oral CapsuleSCDbe59f8b4-7842-42cc-9559-bfa747f0baa56
1091139Metadate CD 10 MG 24 HR Extended Release Oral CapsuleSYbe59f8b4-7842-42cc-9559-bfa747f0baa56
1091163Metadate CD 20 MG 24HR Extended Release Oral CapsuleSYbe59f8b4-7842-42cc-9559-bfa747f0baa56
1091178Metadate CD 30 MG 24HR Extended Release Oral CapsuleSYbe59f8b4-7842-42cc-9559-bfa747f0baa56
1091193Metadate CD 40 MG 24HR Extended Release Oral CapsuleSYbe59f8b4-7842-42cc-9559-bfa747f0baa56
1091204Metadate CD 50 MG 24HR Extended Release Oral CapsuleSYbe59f8b4-7842-42cc-9559-bfa747f0baa56
1091220Metadate CD 60 MG 24HR Extended Release Oral CapsuleSYbe59f8b4-7842-42cc-9559-bfa747f0baa56
1806181methylphenidate HCl 10 MG 30/70 Release 24HR Extended Release Oral CapsuleSYbe59f8b4-7842-42cc-9559-bfa747f0baa56
1806187methylphenidate HCl 20 MG 30/70 Release 24HR Extended Release Oral CapsuleSYbe59f8b4-7842-42cc-9559-bfa747f0baa56
1806189methylphenidate HCl 30 MG 30/70 Release 24HR Extended Release Oral CapsuleSYbe59f8b4-7842-42cc-9559-bfa747f0baa56
1806191methylphenidate HCl 40 MG 30/70 Release 24HR Extended Release Oral CapsuleSYbe59f8b4-7842-42cc-9559-bfa747f0baa56
1806193methylphenidate HCl 50 MG 30/70 Release 24HR Extended Release Oral CapsuleSYbe59f8b4-7842-42cc-9559-bfa747f0baa56
1806197methylphenidate HCl 60 MG 30/70 Release 24HR Extended Release Oral CapsuleSYbe59f8b4-7842-42cc-9559-bfa747f0baa56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69654-582-306965405823030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69654-582-30) 2024-02-22NoNoHistorical