Methylphenidate Hydrochloride

Product NDC
43598-440
11-digit product format
435980440
Labeler code
43598
Product ID
43598-440_528a86ce-1037-944a-e934-15846984dd73
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
2026-09-30
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
36 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
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 · 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 · 148 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213473-001METHYLPHENIDATE 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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213473-001METHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213473-002METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213473-003METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213473-004METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213473-001METHYLPHENIDATE HYDROCHLORIDE18MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A213473-002METHYLPHENIDATE HYDROCHLORIDE27MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A213473-003METHYLPHENIDATE HYDROCHLORIDE36MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A213473-004METHYLPHENIDATE HYDROCHLORIDE54MGTABLET, EXTENDED RELEASE / ORALAB2020-07-29d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213473-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213473-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213473-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213473-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213473-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213473-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213473-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213473-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213473-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213473-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213473-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213473-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213473-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213473-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213473-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213473-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213473-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213473-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213473-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213473-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213473-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213473-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213473-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213473-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213473-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213473-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213473-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213473-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213473-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213473-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213473-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213473-004AB15bbf6a4d5a75…
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Methylphenidate Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE36 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
7124df7e-6273-a68d-6e35-dc06122d8686Available 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
43598-440-01Methylphenidate Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-440-01EA - Each43598-4405ea257a1-090f-4882-a01a-626cf9ed76af12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-440METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [DR.REDDYS LABORATORIES INC]5Current NDC, Legacy NDC, 1 package rows20200820_7124df7e-6273-a68d-6e35-dc06122d8686.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 HYDROCHLORIDEDr.Reddys Laboratories Inc7124df7e-6273-a68d-6e35-dc06122d86862021-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213473
application number: ANDA213473
ndc (product): 43598-440

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
43598-440-0143598044001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-440-01) 2020-08-202026-09-30NoNoCurrent