Methylphenidate Hydrochloride (LA)

Product NDC
51862-609
11-digit product format
518620609
Labeler code
51862
Product ID
51862-609_a2518b74-defc-45ef-915c-b7a8e9fc2dc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Mayne Pharma
Application
ANDA200886
Marketing category
ANDA
Marketing start
2019-05-01
Marketing end
0000-00-00
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct51862-609DDiscontinued by firm2026-08-03
excluded packagepackage51862-60951862-609-01DDiscontinued by firm2026-08-03

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct51862-609DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51862-60951862-609-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200886-001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200886-001AB1

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-263f01610625f2…
2019-09-15 20:21 UTC2019-09A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A200886-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12018-02-26cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A200886-001AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200886-001AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200886-001AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200886-001AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200886-001AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200886-001AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200886-001AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200886-001AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200886-001AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200886-001AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200886-001AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200886-001AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200886-001AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200886-001AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200886-001AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200886-001AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200886-001AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200886-001AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200886-001AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200886-001AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200886-001AB1187673890dc5c…
2021-03-12 10:30 UTC2021-03A200886-001AB115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200886-001AB118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200886-001AB11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200886-001AB113f01610625f2…
2019-09-15 20:21 UTC2019-09A200886-001AB11b00525d2431f…
2019-07-19 19:46 UTC2019-07A200886-001AB11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200886-001AB116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200886-001AB111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200886-001AB11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200886-001AB11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200886-001AB119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200886-001AB11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200886-001AB113f0d92c62455…
2023-05-13 08:27 UTC2023-05A200886-001AB11053a50430f4f…
2023-01-26 05:58 UTC2023-01A200886-001AB113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200886-001AB113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200886-001AB11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200886-001AB11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A200886-001AB11cb3db0bc1861…

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
51862-609-01Methylphenidate Hydrochloride (LA)100 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51862-609-01EA - Each51862-609298834db-c6a9-40f1-845a-e5ecbfd0cf3712019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51862-609METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [MAYNE PHARMA]8Legacy NDC, 1 package rows20250406_e5db854a-1c77-4faf-9e60-daf9c9b6cfa0.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylphenidate Hydrochloride (LA)METHYLPHENIDATE HYDROCHLORIDEMayne Pharmae5db854a-1c77-4faf-9e60-daf9c9b6cfa02025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 51862-609
Methylphenidate Hydrochloride (LA)METHYLPHENIDATE HYDROCHLORIDEDr. Reddy's Laboratories Incd8c14df4-ac05-d69d-9308-58a51d5683292025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200886
application number: ANDA200886

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1806195methylphenidate HCl 10 MG 50/50 Release 24HR Extended Release Oral CapsulePSNe5db854a-1c77-4faf-9e60-daf9c9b6cfa010
1806177methylphenidate HCl 20 MG 50/50 Release 24HR Extended Release Oral CapsulePSNe5db854a-1c77-4faf-9e60-daf9c9b6cfa010
1806179methylphenidate HCl 30 MG 50/50 Release 24HR Extended Release Oral CapsulePSNe5db854a-1c77-4faf-9e60-daf9c9b6cfa010
1806183methylphenidate HCl 40 MG 50/50 Release 24HR Extended Release Oral CapsulePSNe5db854a-1c77-4faf-9e60-daf9c9b6cfa010
1806185methylphenidate HCl 60 MG 50/50 Release 24HR Extended Release Oral CapsulePSNe5db854a-1c77-4faf-9e60-daf9c9b6cfa010
180619550/50 Release 24 HR methylphenidate hydrochloride 10 MG Extended Release Oral CapsuleSCDe5db854a-1c77-4faf-9e60-daf9c9b6cfa010
180617750/50 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral CapsuleSCDe5db854a-1c77-4faf-9e60-daf9c9b6cfa010
180617950/50 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral CapsuleSCDe5db854a-1c77-4faf-9e60-daf9c9b6cfa010
180618350/50 Release 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral CapsuleSCDe5db854a-1c77-4faf-9e60-daf9c9b6cfa010
180618550/50 Release 24 HR methylphenidate hydrochloride 60 MG Extended Release Oral CapsuleSCDe5db854a-1c77-4faf-9e60-daf9c9b6cfa010
1806195methylphenidate HCl 10 MG 50/50 Release 24HR Extended Release Oral CapsuleSYe5db854a-1c77-4faf-9e60-daf9c9b6cfa010
1806177methylphenidate HCl 20 MG 50/50 Release 24HR Extended Release Oral CapsuleSYe5db854a-1c77-4faf-9e60-daf9c9b6cfa010
1806179methylphenidate HCl 30 MG 50/50 Release 24HR Extended Release Oral CapsuleSYe5db854a-1c77-4faf-9e60-daf9c9b6cfa010
1806183methylphenidate HCl 40 MG 50/50 Release 24HR Extended Release Oral CapsuleSYe5db854a-1c77-4faf-9e60-daf9c9b6cfa010
1806185methylphenidate HCl 60 MG 50/50 Release 24HR Extended Release Oral CapsuleSYe5db854a-1c77-4faf-9e60-daf9c9b6cfa010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51862-609-0151862060901100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51862-609-01) 2019-05-010000-00-00NoNoCurrent