Methylphenidate Hydrochloride

Product NDC
60687-543
11-digit product format
606870543
Labeler code
60687
Product ID
60687-543_4522b794-5c43-44cd-e063-6394a90ab39a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA211009
Marketing category
ANDA
Marketing start
2020-06-25
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
27 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

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
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct60687-543DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60687-54360687-543-21DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Methylphenidate Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE27 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4B3SC438HIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1091155Internal RxNorm lookup
1091170Internal RxNorm lookup
1091185Internal RxNorm lookup
1091210Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f6581305-cd1e-4171-8c1b-e184c7bde033Available on FDA.report

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
60687-543-11Methylphenidate Hydrochloride1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE16
60687-543-21Methylphenidate Hydrochloride30 in 1 BOX, UNIT-DOSETABLET, EXTENDED RELEASE306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-543-11EA - Each60687-5439b3f8878-a915-4408-b3f5-5a752c8d8c1d12020-07-13
60687-543-21EA - Each60687-543117a084e-e72e-4b1e-a7bb-61b3bff10fd112020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-543METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 2 package rows20240922_f6581305-cd1e-4171-8c1b-e184c7bde033.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
ndc (product): 60687-543
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 TabletPSNf6581305-cd1e-4171-8c1b-e184c7bde0336
1091170methylphenidate HCl 27 MG 24HR Extended Release Oral TabletPSNf6581305-cd1e-4171-8c1b-e184c7bde0336
1091185methylphenidate HCl 36 MG 24HR Extended Release Oral TabletPSNf6581305-cd1e-4171-8c1b-e184c7bde0336
1091210methylphenidate HCl 54 MG 24HR Extended Release Oral TabletPSNf6581305-cd1e-4171-8c1b-e184c7bde0336
109115524 HR methylphenidate hydrochloride 18 MG Extended Release Oral TabletSCDf6581305-cd1e-4171-8c1b-e184c7bde0336
109117024 HR methylphenidate hydrochloride 27 MG Extended Release Oral TabletSCDf6581305-cd1e-4171-8c1b-e184c7bde0336
109118524 HR methylphenidate hydrochloride 36 MG Extended Release Oral TabletSCDf6581305-cd1e-4171-8c1b-e184c7bde0336
109121024 HR methylphenidate hydrochloride 54 MG Extended Release Oral TabletSCDf6581305-cd1e-4171-8c1b-e184c7bde0336
1091155methylphenidate hydrochloride 18 MG 24 HR Extended Release Oral TabletSYf6581305-cd1e-4171-8c1b-e184c7bde0336
1091170methylphenidate hydrochloride 27 MG 24 HR Extended Release Oral TabletSYf6581305-cd1e-4171-8c1b-e184c7bde0336
1091185methylphenidate hydrochloride 36 MG 24 HR Extended Release Oral TabletSYf6581305-cd1e-4171-8c1b-e184c7bde0336
1091210methylphenidate hydrochloride 54 MG 24 HR Extended Release Oral TabletSYf6581305-cd1e-4171-8c1b-e184c7bde0336

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-543-11606870543111 in 1 BLISTER PACKHistorical
60687-543-216068705432130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-543-21) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-543-11) 30 blister pack2020-06-250000-00-00NoNoCurrent