FDA.reportPublic FDA data

Methylphenidate Hydrochloride

Product NDC
70010-016
11-digit product format
700100016
Labeler code
70010
Product ID
70010-016_40a67d01-89e6-a878-e063-6394a90ae051
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA211796
Marketing category
ANDA
Marketing start
2019-09-10
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
60 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

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211796-001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23
A211796-002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23
A211796-003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23
A211796-004METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23
A211796-005METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB1RS2019-05-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A211796-001AB1
A211796-002AB1
A211796-003AB1
A211796-004AB1
A211796-005AB1

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 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211796-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211796-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211796-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211796-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211796-005METHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211796-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211796-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211796-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211796-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211796-005METHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A211796-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211796-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211796-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211796-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211796-005METHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211796-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211796-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211796-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211796-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211796-005METHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211796-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211796-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211796-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211796-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211796-005METHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211796-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211796-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211796-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211796-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211796-005METHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211796-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211796-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211796-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211796-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211796-005METHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211796-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211796-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211796-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211796-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211796-005METHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-235bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211796-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211796-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211796-003AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211796-004AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211796-005AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211796-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211796-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211796-003AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211796-004AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211796-005AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211796-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211796-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211796-003AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211796-004AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211796-005AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211796-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211796-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211796-003AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211796-004AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211796-005AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211796-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211796-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211796-003AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211796-004AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211796-005AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211796-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211796-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211796-003AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211796-004AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211796-005AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211796-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211796-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211796-003AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211796-004AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211796-005AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211796-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211796-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211796-003AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211796-004AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211796-005AB115bbf6a4d5a75…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE60 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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1806177Internal RxNorm lookup
1806179Internal RxNorm lookup
1806183Internal RxNorm lookup
1806185Internal RxNorm lookup
1806195Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
27ea91ad-f64e-43d7-ab10-6f988bca5379Available 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
70010-016-03Methylphenidate Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-016-03EA - Each70010-016cb30117a-9fb4-4f1b-90a0-e6be3f571d1112019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-016METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 1 package rows20241207_27ea91ad-f64e-43d7-ab10-6f988bca5379.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEGranules Pharmaceuticals Inc.27ea91ad-f64e-43d7-ab10-6f988bca53792025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211796
application number: ANDA211796
ndc (product): 70010-016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1806195methylphenidate HCl 10 MG 50/50 Release 24HR Extended Release Oral CapsulePSN27ea91ad-f64e-43d7-ab10-6f988bca537912
1806177methylphenidate HCl 20 MG 50/50 Release 24HR Extended Release Oral CapsulePSN27ea91ad-f64e-43d7-ab10-6f988bca537912
1806179methylphenidate HCl 30 MG 50/50 Release 24HR Extended Release Oral CapsulePSN27ea91ad-f64e-43d7-ab10-6f988bca537912
1806183methylphenidate HCl 40 MG 50/50 Release 24HR Extended Release Oral CapsulePSN27ea91ad-f64e-43d7-ab10-6f988bca537912
1806185methylphenidate HCl 60 MG 50/50 Release 24HR Extended Release Oral CapsulePSN27ea91ad-f64e-43d7-ab10-6f988bca537912
180619550/50 Release 24 HR methylphenidate hydrochloride 10 MG Extended Release Oral CapsuleSCD27ea91ad-f64e-43d7-ab10-6f988bca537912
180617750/50 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral CapsuleSCD27ea91ad-f64e-43d7-ab10-6f988bca537912
180617950/50 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral CapsuleSCD27ea91ad-f64e-43d7-ab10-6f988bca537912
180618350/50 Release 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral CapsuleSCD27ea91ad-f64e-43d7-ab10-6f988bca537912
180618550/50 Release 24 HR methylphenidate hydrochloride 60 MG Extended Release Oral CapsuleSCD27ea91ad-f64e-43d7-ab10-6f988bca537912
1806195methylphenidate HCl 10 MG 50/50 Release 24HR Extended Release Oral CapsuleSY27ea91ad-f64e-43d7-ab10-6f988bca537912
1806177methylphenidate HCl 20 MG 50/50 Release 24HR Extended Release Oral CapsuleSY27ea91ad-f64e-43d7-ab10-6f988bca537912
1806179methylphenidate HCl 30 MG 50/50 Release 24HR Extended Release Oral CapsuleSY27ea91ad-f64e-43d7-ab10-6f988bca537912
1806183methylphenidate HCl 40 MG 50/50 Release 24HR Extended Release Oral CapsuleSY27ea91ad-f64e-43d7-ab10-6f988bca537912
1806185methylphenidate HCl 60 MG 50/50 Release 24HR Extended Release Oral CapsuleSY27ea91ad-f64e-43d7-ab10-6f988bca537912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70010-016-037001000160330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-016-03) 2019-09-100000-00-00NoNoCurrent