Methylphenidate Hydrochloride

Product NDC: 27808-059
11-digit product format: 278080059
Labeler code: 27808
Product ID: 27808-059_2b5b76ed-a330-4f7b-a111-467a067ee663
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylphenidate Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Cranbury Pharmaceuticals, LLC
Application: ANDA091601
Marketing category: ANDA
Marketing start: 2015-03-04
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 10 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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091601-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2010-07-23
A091601-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA		2010-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091601-001	AA
A091601-002	AA

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091601-001	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091601-002	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION / ORAL	AA	2010-07-23	`782e0a99824c…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A091601-001	AA	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A091601-002	AA	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLPHENIDATE HYDROCHLORIDE	10 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4B3SC438HI	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
e817377f-bc72-415a-acd2-7136746b2479	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
143536be-f21a-464c-bc5a-163f5c171815	Product name	2	20250626
fd4d0878-dcea-3832-288e-e3bbbbe580ff	Product name	9	20240516
435f0341-cf24-41d5-8fbf-c909821e5596	Product name	1	20230313
c9b6eabb-08d7-bb2d-e81a-06be3590b436	Product name	2	20221216
67aa32c6-44f4-50de-64dd-643e8caf420d	Product name	6	20210622
50b24f34-96fa-4f1e-b262-b0baf4a4a440	Product name	4	20210513
cf83c421-eebe-4de2-b1a2-fd96e3dbfcf8	Product name	1	20200128
166d1d2d-dd55-4fdf-82e2-b83a3c5347c1	Product name	1	20190828
343a61d5-785d-cc27-a43a-0779da054d88	Product name	3	20190828
7607489b-cd15-3103-f3b1-d4283574d250	Product name	2	20190614
407f0cce-da29-4050-a512-2cabe9e5692d	Product name	9	20190611
f7f4bf1e-7c67-46c6-8c42-9beb1a06b38e	Product name	2	20190415
190572d9-6c7b-4b40-8172-c1b5f802c20f	Product name	1	20180724
2948856e-f76e-d380-d9ed-b317efafbc98	Product name	5	20180423
c0aa09de-7aa1-4a98-8f70-62ec3c97c695	Product name	1	20170803
3317aade-2d6e-f159-9fe6-e8385a825178	Product name	3	20160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3	Product name	1	20160111

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
27808-059-01	Methylphenidate Hydrochloride	500 mL in 1 BOTTLE, PLASTIC	SOLUTION	500		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
27808-059-01	ML - Milliliter	27808-059	c1157441-f27e-488e-a879-e285d4e9dc71	1	2017-10-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHYLPHENIDATE HYDROCHLORIDE	ACTIVE INGREDIENT	4B3SC438HI	METHYLPHENIDATE HYDROCHLORIDE SOLUTION [TRIS PHARMA INC]	8
METHYLPHENIDATE	ACTIVE MOIETY	207ZZ9QZ49	METHYLPHENIDATE HYDROCHLORIDE SOLUTION [TRIS PHARMA INC]	8
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	METHYLPHENIDATE HYDROCHLORIDE SOLUTION [TRIS PHARMA INC]	8
GRAPE	INACTIVE INGREDIENT	6X543N684K	METHYLPHENIDATE HYDROCHLORIDE SOLUTION [TRIS PHARMA INC]	8
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	METHYLPHENIDATE HYDROCHLORIDE SOLUTION [TRIS PHARMA INC]	8
POLYETHYLENE GLYCOL 1450	INACTIVE INGREDIENT	OJ4Z5Z32L4	METHYLPHENIDATE HYDROCHLORIDE SOLUTION [TRIS PHARMA INC]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	METHYLPHENIDATE HYDROCHLORIDE SOLUTION [TRIS PHARMA INC]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27808-059	METHYLPHENIDATE HYDROCHLORIDE SOLUTION [CRANBURY PHARMACEUTICALS, LLC]	22	Current NDC, Legacy NDC, 1 package rows	20250326_e817377f-bc72-415a-acd2-7136746b2479.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Cranbury Pharmaceuticals, LLC	e817377f-bc72-415a-acd2-7136746b2479	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091601 application number: ANDA091601 ndc (product): 27808-059
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	83e70f8f-18dd-45fc-8bc5-4b8f7f23439e	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091601 application number: ANDA091601
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	ad3a3865-952e-46cf-8387-1228e2375312	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091601 application number: ANDA091601

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4B3SC438HI	METHYLPHENIDATE HYDROCHLORIDE	23655-65-4	METHYLPHENIDATE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1091133	methylphenidate HCl 10 MG in 5 mL Oral Solution	PSN	83e70f8f-18dd-45fc-8bc5-4b8f7f23439e	102
1091133	methylphenidate hydrochloride 2 MG/ML Oral Solution	SCD	83e70f8f-18dd-45fc-8bc5-4b8f7f23439e	102
1091133	methylphenidate HCl 10 MG per 5 ML Oral Solution	SY	83e70f8f-18dd-45fc-8bc5-4b8f7f23439e	102
1091133	methylphenidate hydrochloride 10 MG per 5 ML Oral Solution	SY	83e70f8f-18dd-45fc-8bc5-4b8f7f23439e	102
1091133	methylphenidate HCl 10 MG in 5 mL Oral Solution	PSN	e817377f-bc72-415a-acd2-7136746b2479	22
1091341	methylphenidate HCl 5 MG in 5 mL Oral Solution	PSN	e817377f-bc72-415a-acd2-7136746b2479	22
1091341	methylphenidate hydrochloride 1 MG/ML Oral Solution	SCD	e817377f-bc72-415a-acd2-7136746b2479	22
1091133	methylphenidate hydrochloride 2 MG/ML Oral Solution	SCD	e817377f-bc72-415a-acd2-7136746b2479	22
1091341	methylphenidate HCl 10 MG per 10 ML Oral Solution	SY	e817377f-bc72-415a-acd2-7136746b2479	22
1091133	methylphenidate HCl 10 MG per 5 ML Oral Solution	SY	e817377f-bc72-415a-acd2-7136746b2479	22
1091341	methylphenidate HCl 5 MG per 5 ML Oral Solution	SY	e817377f-bc72-415a-acd2-7136746b2479	22
1091133	methylphenidate hydrochloride 10 MG per 5 ML Oral Solution	SY	e817377f-bc72-415a-acd2-7136746b2479	22
1091341	methylphenidate hydrochloride 5 MG per 5 ML Oral Solution	SY	e817377f-bc72-415a-acd2-7136746b2479	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
27808-059-01	27808005901	500 mL in 1 BOTTLE, PLASTIC (27808-059-01)	500 ml	2015-03-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylphenidate Hydrochloride	Cranbury Pharmaceuticals, LLC	2025-01-30	HUMAN PRESCRIPTION DRUG LABEL	22
Methylphenidate Hydrochloride	Bryant Ranch Prepack	2024-04-03	HUMAN PRESCRIPTION DRUG LABEL	102