Methylphenidate Hydrochloride

Product NDC
64720-401
11-digit product format
647200401
Labeler code
64720
Product ID
64720-401_72cf9b08-1cc5-423e-b51e-95e57e6665c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
CorePharma, LLC
Application
ANDA205105
Marketing category
ANDA
Marketing start
2016-09-20
Marketing end
2019-12-01
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64720-401DDiscontinued by firm2026-08-10
excluded packagepackage64720-40164720-401-10DDiscontinued by firm2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64720-401-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64720-401-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64720-401-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64720-401-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64720-401-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64720-401-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64720-401-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64720-401-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64720-401-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64720-401-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64720-401-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64720-401-10557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205105-001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28
A205105-002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28
A205105-003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28
A205105-004METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28
A205105-005METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE50MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28
A205105-006METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A205105-001AB2
A205105-002AB2
A205105-003AB2
A205105-004AB2
A205105-005AB2
A205105-006AB2

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A205105-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205105-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205105-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205105-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205105-005METHYLPHENIDATE HYDROCHLORIDE50MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205105-006METHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205105-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205105-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205105-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205105-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205105-005METHYLPHENIDATE HYDROCHLORIDE50MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205105-006METHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A205105-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205105-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205105-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205105-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205105-005METHYLPHENIDATE HYDROCHLORIDE50MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205105-006METHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205105-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205105-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205105-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205105-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205105-005METHYLPHENIDATE HYDROCHLORIDE50MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205105-006METHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205105-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205105-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205105-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205105-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205105-005METHYLPHENIDATE HYDROCHLORIDE50MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205105-006METHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205105-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205105-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205105-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205105-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205105-005METHYLPHENIDATE HYDROCHLORIDE50MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205105-006METHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205105-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205105-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205105-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205105-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB22016-07-282680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A205105-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205105-002AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205105-003AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205105-004AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205105-005AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205105-006AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205105-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205105-002AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205105-003AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205105-004AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205105-005AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205105-006AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205105-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205105-002AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205105-003AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205105-004AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205105-005AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205105-006AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205105-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205105-002AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205105-003AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205105-004AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205105-005AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205105-006AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205105-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205105-002AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205105-003AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205105-004AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205105-005AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205105-006AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205105-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205105-002AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205105-003AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205105-004AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205105-005AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205105-006AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205105-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205105-002AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205105-003AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205105-004AB212680178bc6a6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64720-401-10EA - Each64720-4019d8661cc-c772-4013-84ac-19410f3b881a12016-10-06

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLC10aa0dc0-bd0e-4927-a19a-8722d78ad67d2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205105
application number: ANDA205105