Methylphenidate Hydrochloride

Product NDC
50268-545
11-digit product format
502680545
Labeler code
50268
Product ID
50268-545_47e731b7-b64e-317b-e063-6294a90a2c8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
AvPAK
Application
ANDA211009
Marketing category
ANDA
Marketing start
2021-04-22
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
18 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 productproduct50268-545DDiscontinued by firm2026-09-14
excluded packagepackage50268-54550268-545-12DDiscontinued by firm2026-09-14

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211009-001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2019-09-03
A211009-002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2019-09-03
A211009-003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2019-09-03
A211009-004METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2019-09-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A211009-001AB
A211009-002AB
A211009-003AB
A211009-004AB

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 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211009-001METHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2019-09-0384e616aacf4f…
2026-09-14 22:38:342026-08A211009-002METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2019-09-0384e616aacf4f…
2026-09-14 22:38:342026-08A211009-003METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2019-09-0384e616aacf4f…
2026-09-14 22:38:342026-08A211009-004METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2019-09-0384e616aacf4f…
2026-08-18 06:07:402026-07A211009-001METHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2019-09-03caaa826d4ba7…
2026-08-18 06:07:402026-07A211009-002METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2019-09-03caaa826d4ba7…
2026-08-18 06:07:402026-07A211009-003METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2019-09-03caaa826d4ba7…
2026-08-18 06:07:402026-07A211009-004METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2019-09-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211009-001METHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2019-09-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211009-002METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2019-09-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211009-003METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2019-09-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211009-004METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2019-09-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211009-001METHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2019-09-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211009-002METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2019-09-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211009-003METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2019-09-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211009-004METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2019-09-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A211009-001METHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2019-09-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211009-002METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2019-09-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211009-003METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2019-09-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211009-004METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2019-09-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211009-001METHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2019-09-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211009-002METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2019-09-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211009-003METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2019-09-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211009-004METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2019-09-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211009-001METHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2019-09-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211009-002METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2019-09-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211009-003METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2019-09-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211009-004METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2019-09-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211009-001METHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2019-09-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211009-002METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2019-09-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211009-003METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2019-09-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211009-004METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2019-09-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211009-001METHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2019-09-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211009-002METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2019-09-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211009-003METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2019-09-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211009-004METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2019-09-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211009-001METHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2019-09-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211009-002METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2019-09-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211009-003METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2019-09-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211009-004METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2019-09-035bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A211009-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A211009-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A211009-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A211009-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A211009-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211009-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211009-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211009-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211009-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211009-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211009-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211009-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211009-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211009-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211009-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211009-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211009-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211009-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211009-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211009-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211009-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211009-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211009-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211009-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211009-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211009-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211009-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211009-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211009-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211009-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211009-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211009-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211009-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211009-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211009-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211009-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211009-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211009-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211009-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211009-004AB15bbf6a4d5a75…

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
50268-545-11Methylphenidate Hydrochloride1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE14
50268-545-12Methylphenidate Hydrochloride20 in 1 BOXTABLET, EXTENDED RELEASE204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-545-11EA - Each50268-5453b2eb426-ed3a-4cc4-8b43-8e12cfc0864a12021-05-05
50268-545-12EA - Each50268-54523824907-727b-4455-80f6-660889cd895b12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-545METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [AVPAK]3Current NDC, Legacy NDC, 2 package rows20240110_c0906610-294d-1320-e053-2995a90ad8fd.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEAmerican Health Packagingf6581305-cd1e-4171-8c1b-e184c7bde0332025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211009
application number: ANDA211009
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceuticals, Inc.b9af3104-172d-4975-9301-b9fe7db9ef122021-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211009
application number: ANDA211009
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals, Inc.b07150db-fd99-4400-bb83-b3a7544a917a2021-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211009
application number: ANDA211009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091155methylphenidate HCl 18 MG 24HR Extended Release Oral TabletPSNc0906610-294d-1320-e053-2995a90ad8fd4
1091170methylphenidate HCl 27 MG 24HR Extended Release Oral TabletPSNc0906610-294d-1320-e053-2995a90ad8fd4
1091185methylphenidate HCl 36 MG 24HR Extended Release Oral TabletPSNc0906610-294d-1320-e053-2995a90ad8fd4
1091210methylphenidate HCl 54 MG 24HR Extended Release Oral TabletPSNc0906610-294d-1320-e053-2995a90ad8fd4
109115524 HR methylphenidate hydrochloride 18 MG Extended Release Oral TabletSCDc0906610-294d-1320-e053-2995a90ad8fd4
109117024 HR methylphenidate hydrochloride 27 MG Extended Release Oral TabletSCDc0906610-294d-1320-e053-2995a90ad8fd4
109118524 HR methylphenidate hydrochloride 36 MG Extended Release Oral TabletSCDc0906610-294d-1320-e053-2995a90ad8fd4
109121024 HR methylphenidate hydrochloride 54 MG Extended Release Oral TabletSCDc0906610-294d-1320-e053-2995a90ad8fd4
1091155methylphenidate hydrochloride 18 MG 24 HR Extended Release Oral TabletSYc0906610-294d-1320-e053-2995a90ad8fd4
1091170methylphenidate hydrochloride 27 MG 24 HR Extended Release Oral TabletSYc0906610-294d-1320-e053-2995a90ad8fd4
1091185methylphenidate hydrochloride 36 MG 24 HR Extended Release Oral TabletSYc0906610-294d-1320-e053-2995a90ad8fd4
1091210methylphenidate hydrochloride 54 MG 24 HR Extended Release Oral TabletSYc0906610-294d-1320-e053-2995a90ad8fd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-545-11502680545111 in 1 BLISTER PACKHistorical
50268-545-125026805451220 BLISTER PACK in 1 BOX (50268-545-12) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-545-11) 20 blister pack2021-04-220000-00-00NoNoCurrent