Methylphenidate Hydrochloride

Product NDC
71930-024
Requested package NDC
71930-024-52
11-digit product format
719300024
Labeler code
71930
Product ID
71930-024_2ec047c6-e9ea-4093-bb03-1b3f80fb2a13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Eywa Pharma Inc
Application
ANDA210139
Marketing category
ANDA
Marketing start
2019-03-29
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
5 mg/5mL
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210139-001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-10-03
A210139-002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE10MG/5MLSOLUTION / ORALAA2018-10-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A210139-001AA
A210139-002AA

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210139-001METHYLPHENIDATE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210139-002METHYLPHENIDATE HYDROCHLORIDE10MG/5MLSOLUTION / ORALAA2018-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210139-001METHYLPHENIDATE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210139-002METHYLPHENIDATE HYDROCHLORIDE10MG/5MLSOLUTION / ORALAA2018-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A210139-001METHYLPHENIDATE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210139-002METHYLPHENIDATE HYDROCHLORIDE10MG/5MLSOLUTION / ORALAA2018-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210139-001METHYLPHENIDATE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210139-002METHYLPHENIDATE HYDROCHLORIDE10MG/5MLSOLUTION / ORALAA2018-10-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210139-001METHYLPHENIDATE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210139-002METHYLPHENIDATE HYDROCHLORIDE10MG/5MLSOLUTION / ORALAA2018-10-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210139-001METHYLPHENIDATE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210139-002METHYLPHENIDATE HYDROCHLORIDE10MG/5MLSOLUTION / ORALAA2018-10-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210139-001METHYLPHENIDATE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210139-002METHYLPHENIDATE HYDROCHLORIDE10MG/5MLSOLUTION / ORALAA2018-10-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210139-001METHYLPHENIDATE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210139-002METHYLPHENIDATE HYDROCHLORIDE10MG/5MLSOLUTION / ORALAA2018-10-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210139-001METHYLPHENIDATE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-10-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210139-002METHYLPHENIDATE HYDROCHLORIDE10MG/5MLSOLUTION / ORALAA2018-10-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210139-001METHYLPHENIDATE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-10-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A210139-002METHYLPHENIDATE HYDROCHLORIDE10MG/5MLSOLUTION / ORALAA2018-10-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210139-001METHYLPHENIDATE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-10-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210139-002METHYLPHENIDATE HYDROCHLORIDE10MG/5MLSOLUTION / ORALAA2018-10-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210139-001METHYLPHENIDATE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-10-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210139-002METHYLPHENIDATE HYDROCHLORIDE10MG/5MLSOLUTION / ORALAA2018-10-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210139-001METHYLPHENIDATE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-10-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210139-002METHYLPHENIDATE HYDROCHLORIDE10MG/5MLSOLUTION / ORALAA2018-10-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210139-001METHYLPHENIDATE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-10-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210139-002METHYLPHENIDATE HYDROCHLORIDE10MG/5MLSOLUTION / ORALAA2018-10-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210139-001METHYLPHENIDATE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-10-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210139-002METHYLPHENIDATE HYDROCHLORIDE10MG/5MLSOLUTION / ORALAA2018-10-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210139-001METHYLPHENIDATE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-10-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210139-002METHYLPHENIDATE HYDROCHLORIDE10MG/5MLSOLUTION / ORALAA2018-10-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210139-001METHYLPHENIDATE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-10-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210139-002METHYLPHENIDATE HYDROCHLORIDE10MG/5MLSOLUTION / ORALAA2018-10-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210139-001METHYLPHENIDATE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-10-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210139-002METHYLPHENIDATE HYDROCHLORIDE10MG/5MLSOLUTION / ORALAA2018-10-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210139-001METHYLPHENIDATE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-10-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210139-002METHYLPHENIDATE HYDROCHLORIDE10MG/5MLSOLUTION / ORALAA2018-10-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210139-001METHYLPHENIDATE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-10-03782e0a99824c…
2021-12-28 21:50 UTC2021-12A210139-002METHYLPHENIDATE HYDROCHLORIDE10MG/5MLSOLUTION / ORALAA2018-10-03782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210139-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210139-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210139-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210139-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210139-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210139-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210139-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210139-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210139-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210139-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210139-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210139-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210139-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210139-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210139-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210139-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210139-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210139-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210139-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210139-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210139-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210139-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210139-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210139-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210139-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210139-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210139-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210139-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210139-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210139-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210139-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210139-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210139-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210139-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210139-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210139-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210139-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210139-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210139-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A210139-002AA1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE5 mg/5mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1091133Internal RxNorm lookup
1091341Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
298fb86d-7d94-49e1-b743-3e7801122422Available 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
71930-024-52Methylphenidate Hydrochloride500 mL in 1 BOTTLESOLUTION5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71930-024-52ML - Milliliter71930-02480134538-7f47-41f5-8f13-26a4e6d7542d12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71930-024METHYLPHENIDATE HYDROCHLORIDE SOLUTION [EYWA PHARMA INC]6Current NDC, Legacy NDC, 1 package rows20231111_298fb86d-7d94-49e1-b743-3e7801122422.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackb9c31526-d486-433c-9b3c-7a12765afe942024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210139
application number: ANDA210139
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackea5a6d4e-60ba-46f3-b314-3c7a970b377d2024-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210139
application number: ANDA210139
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack213ca0da-dde8-48ee-ac8c-c66558e6f62d2024-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210139
application number: ANDA210139
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackb49863bd-20ba-44d5-8dab-96fcbd276a5c2024-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210139
application number: ANDA210139
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEEywa Pharma Inc298fb86d-7d94-49e1-b743-3e78011224222023-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210139
application number: ANDA210139
ndc (package): 71930-024-52
ndc (product): 71930-024
ndc11 (package): 71930002452

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091341methylphenidate HCl 5 MG in 5 mL Oral SolutionPSNea5a6d4e-60ba-46f3-b314-3c7a970b377d102
1091341methylphenidate hydrochloride 1 MG/ML Oral SolutionSCDea5a6d4e-60ba-46f3-b314-3c7a970b377d102
1091341methylphenidate HCl 10 MG per 10 ML Oral SolutionSYea5a6d4e-60ba-46f3-b314-3c7a970b377d102
1091341methylphenidate HCl 5 MG per 5 ML Oral SolutionSYea5a6d4e-60ba-46f3-b314-3c7a970b377d102
1091341methylphenidate hydrochloride 5 MG per 5 ML Oral SolutionSYea5a6d4e-60ba-46f3-b314-3c7a970b377d102
1091341methylphenidate HCl 5 MG in 5 mL Oral SolutionPSNb9c31526-d486-433c-9b3c-7a12765afe94101
1091341methylphenidate hydrochloride 1 MG/ML Oral SolutionSCDb9c31526-d486-433c-9b3c-7a12765afe94101
1091341methylphenidate HCl 10 MG per 10 ML Oral SolutionSYb9c31526-d486-433c-9b3c-7a12765afe94101
1091341methylphenidate HCl 5 MG per 5 ML Oral SolutionSYb9c31526-d486-433c-9b3c-7a12765afe94101
1091341methylphenidate hydrochloride 5 MG per 5 ML Oral SolutionSYb9c31526-d486-433c-9b3c-7a12765afe94101
1091133methylphenidate HCl 10 MG in 5 mL Oral SolutionPSN298fb86d-7d94-49e1-b743-3e78011224226
1091341methylphenidate HCl 5 MG in 5 mL Oral SolutionPSN298fb86d-7d94-49e1-b743-3e78011224226
1091341methylphenidate hydrochloride 1 MG/ML Oral SolutionSCD298fb86d-7d94-49e1-b743-3e78011224226
1091133methylphenidate hydrochloride 2 MG/ML Oral SolutionSCD298fb86d-7d94-49e1-b743-3e78011224226
1091341methylphenidate HCl 10 MG per 10 ML Oral SolutionSY298fb86d-7d94-49e1-b743-3e78011224226
1091133methylphenidate HCl 10 MG per 5 ML Oral SolutionSY298fb86d-7d94-49e1-b743-3e78011224226
1091341methylphenidate HCl 5 MG per 5 ML Oral SolutionSY298fb86d-7d94-49e1-b743-3e78011224226
1091133methylphenidate hydrochloride 10 MG per 5 ML Oral SolutionSY298fb86d-7d94-49e1-b743-3e78011224226
1091341methylphenidate hydrochloride 5 MG per 5 ML Oral SolutionSY298fb86d-7d94-49e1-b743-3e78011224226

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71930-024-5271930002452500 mL in 1 BOTTLE (71930-024-52) 500 ml2019-03-290000-00-00NoNoCurrent