Methylphenidate Hydrochloride

Product NDC
70010-014
11-digit product format
700100014
Labeler code
70010
Product ID
70010-014_5d4e3a29-ca13-9c98-e063-6294a90a682d
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
30 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

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

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 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211796-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-2384e616aacf4f…
2026-09-14 22:38:342026-08A211796-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-2384e616aacf4f…
2026-09-14 22:38:342026-08A211796-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-2384e616aacf4f…
2026-09-14 22:38:342026-08A211796-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-2384e616aacf4f…
2026-09-14 22:38:342026-08A211796-005METHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB1RS2019-05-2384e616aacf4f…
2026-08-18 06:07:402026-07A211796-001METHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07A211796-002METHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07A211796-003METHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07A211796-004METHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB12019-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07A211796-005METHYLPHENIDATE HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB1RS2019-05-23caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211796-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211796-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211796-003AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211796-004AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211796-005AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211796-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A211796-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A211796-003AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A211796-004AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A211796-005AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211796-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211796-002AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211796-003AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211796-004AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211796-005AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211796-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211796-002AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211796-003AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211796-004AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211796-005AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211796-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211796-002AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211796-003AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211796-004AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211796-005AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211796-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211796-002AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211796-003AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211796-004AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211796-005AB118072bd15b7f6…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Methylphenidate Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE30 mg/1

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
70010-014-01Methylphenidate Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-014-01EA - Each70010-01452e5ac55-a230-42b2-9697-a17ed872cf4e12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-014METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 1 package rows20241207_27ea91ad-f64e-43d7-ab10-6f988bca5379.zip

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
70010-014-0170010001401100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-014-01) 2019-09-100000-00-00NoNoCurrent