Methylphenidate Hydrochloride

Product NDC
43598-441
11-digit product format
435980441
Labeler code
43598
Product ID
43598-441_b2e44e65-bff9-7e54-c9e9-6adf1b831b6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Dr.Reddys Laboratories Inc
Application
ANDA213473
Marketing category
ANDA
Marketing start
2020-08-20
Marketing end
0000-00-00
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
54 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct43598-441DDiscontinued by firm2026-10-12
excluded packagepackage43598-44143598-441-01DDiscontinued by firm2026-10-12

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43598-441-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43598-441-01f5e01cc5f278…a2eaf40c39c3…

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
A213473-001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29
A213473-002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29
A213473-003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29
A213473-004METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213473-001AB
A213473-002AB
A213473-003AB
A213473-004AB

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 4 · 156 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213473-001METHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2020-07-2984e616aacf4f…
2026-09-14 22:38:342026-08A213473-002METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2020-07-2984e616aacf4f…
2026-09-14 22:38:342026-08A213473-003METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2020-07-2984e616aacf4f…
2026-09-14 22:38:342026-08A213473-004METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2020-07-2984e616aacf4f…
2026-08-18 06:07:402026-07A213473-001METHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07A213473-002METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07A213473-003METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07A213473-004METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213473-001METHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213473-002METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213473-003METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213473-004METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213473-001METHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2020-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213473-002METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2020-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213473-003METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2020-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213473-004METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2020-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A213473-001METHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2020-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213473-002METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2020-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213473-003METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2020-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213473-004METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2020-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213473-001METHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213473-002METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213473-003METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213473-004METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213473-001METHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213473-002METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213473-003METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213473-004METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213473-001METHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2020-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213473-002METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2020-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213473-003METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2020-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213473-004METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2020-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213473-001METHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2020-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213473-002METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2020-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213473-003METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2020-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213473-004METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2020-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213473-001METHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2020-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213473-002METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2020-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213473-003METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2020-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213473-004METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2020-07-295bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 156 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213473-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213473-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213473-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213473-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213473-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213473-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213473-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213473-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213473-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213473-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213473-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213473-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213473-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213473-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213473-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213473-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213473-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213473-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213473-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213473-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213473-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213473-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213473-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213473-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213473-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213473-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213473-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213473-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213473-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213473-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213473-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213473-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213473-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213473-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213473-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213473-004AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213473-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213473-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213473-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213473-004AB1bb7c543d1eb4…

Reported adverse events (FAERS/openFDA)#

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

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
43598-441-01Methylphenidate Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-441-01EA - Each43598-441da53cd39-9cbc-469e-8e8f-58a83cf9d2fa12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-441METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [DR.REDDYS LABORATORIES INC]5Legacy NDC, 1 package rows20200820_7124df7e-6273-a68d-6e35-dc06122d8686.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091155methylphenidate HCl 18 MG 24HR Extended Release Oral TabletPSN7124df7e-6273-a68d-6e35-dc06122d86867
1091170methylphenidate HCl 27 MG 24HR Extended Release Oral TabletPSN7124df7e-6273-a68d-6e35-dc06122d86867
1091185methylphenidate HCl 36 MG 24HR Extended Release Oral TabletPSN7124df7e-6273-a68d-6e35-dc06122d86867
1091210methylphenidate HCl 54 MG 24HR Extended Release Oral TabletPSN7124df7e-6273-a68d-6e35-dc06122d86867
109115524 HR methylphenidate hydrochloride 18 MG Extended Release Oral TabletSCD7124df7e-6273-a68d-6e35-dc06122d86867
109117024 HR methylphenidate hydrochloride 27 MG Extended Release Oral TabletSCD7124df7e-6273-a68d-6e35-dc06122d86867
109118524 HR methylphenidate hydrochloride 36 MG Extended Release Oral TabletSCD7124df7e-6273-a68d-6e35-dc06122d86867
109121024 HR methylphenidate hydrochloride 54 MG Extended Release Oral TabletSCD7124df7e-6273-a68d-6e35-dc06122d86867
1091155methylphenidate hydrochloride 18 MG 24 HR Extended Release Oral TabletSY7124df7e-6273-a68d-6e35-dc06122d86867
1091170methylphenidate hydrochloride 27 MG 24 HR Extended Release Oral TabletSY7124df7e-6273-a68d-6e35-dc06122d86867
1091185methylphenidate hydrochloride 36 MG 24 HR Extended Release Oral TabletSY7124df7e-6273-a68d-6e35-dc06122d86867
1091210methylphenidate hydrochloride 54 MG 24 HR Extended Release Oral TabletSY7124df7e-6273-a68d-6e35-dc06122d86867

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-441-0143598044101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-441-01) 2020-08-200000-00-00NoNoCurrent