Methylphenidate Hydrochloride

Product NDC: 62175-313
11-digit product format: 621750313
Labeler code: 62175
Product ID: 62175-313_8b133cd2-e3c6-4742-b402-2393b56ffc93
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylphenidate Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA091695
Marketing category: ANDA
Marketing start: 2013-09-23
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: 2027-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091695-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-07-09
A091695-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-07-09
A091695-003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-09-23
A091695-004	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091695-001	BX
A091695-002	BX
A091695-003	BX
A091695-004	BX

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 5 · 164 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	A091695-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091695-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091695-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091695-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091695-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091695-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091695-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091695-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091695-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091695-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091695-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091695-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091695-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091695-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091695-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091695-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091695-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091695-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091695-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091695-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091695-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091695-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091695-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091695-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091695-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091695-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091695-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091695-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091695-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091695-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091695-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091695-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091695-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091695-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091695-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091695-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091695-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091695-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091695-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-09-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091695-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	BX	2013-09-23	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091695-001	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091695-002	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091695-003	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091695-004	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091695-001	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091695-002	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091695-003	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091695-004	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091695-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091695-002	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091695-003	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091695-004	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091695-001	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091695-002	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091695-003	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091695-004	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091695-001	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091695-002	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091695-003	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091695-004	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091695-001	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091695-002	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091695-003	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091695-004	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091695-001	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091695-002	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091695-003	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091695-004	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091695-001	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091695-002	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091695-003	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091695-004	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091695-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091695-002	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091695-003	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091695-004	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091695-001	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091695-002	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091695-003	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091695-004	BX	1	`d06236e962d9…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLPHENIDATE HYDROCHLORIDE	54 mg/1

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2001564	Internal RxNorm lookup
2001565	Internal RxNorm lookup
2001566	Internal RxNorm lookup
2001568	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
3d1f5aff-5d39-496c-b5ed-7f3c70ec641c	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
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
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
3317aade-2d6e-f159-9fe6-e8385a825178	Product name	3	20160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3	Product name	1	20160111
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62175-313-37	Methylphenidate Hydrochloride	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62175-313-37	EA - Each	62175-313	b71f3b83-879b-474f-93f9-3184088ee88f	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHYLPHENIDATE HYDROCHLORIDE	ACTIVE INGREDIENT	4B3SC438HI	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	17
METHYLPHENIDATE	ACTIVE MOIETY	207ZZ9QZ49	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	17
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 400 MPA.S AT 1%)	INACTIVE INGREDIENT	FC40A8XAJ3	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	17
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	17
ETHYLCELLULOSE (10 MPA.S)	INACTIVE INGREDIENT	3DYK7UYZ62	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	17
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	17
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	17
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	17
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	17
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)	INACTIVE INGREDIENT	6N003M473W	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	17
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	17
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	17
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	17
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	17
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	17
SUCROSE	INACTIVE INGREDIENT	C151H8M554	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	17
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	17
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	17
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62175-313	METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]	28	Current NDC, Legacy NDC, 1 package rows	20241025_3d1f5aff-5d39-496c-b5ed-7f3c70ec641c.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	Lannett Company, Inc.	3d1f5aff-5d39-496c-b5ed-7f3c70ec641c	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091695 application number: ANDA091695 ndc (product): 62175-313
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	cd2c1226-fa19-4734-b62d-89fea73dcb0d	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091695 application number: ANDA091695
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	5a29687b-5294-4b27-a556-514b092a877d	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091695 application number: ANDA091695

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
2001564	methylphenidate HCl 18 MG 24HR Extended Release Oral Tablet, BX Rating	PSN	3d1f5aff-5d39-496c-b5ed-7f3c70ec641c	32
2001565	methylphenidate HCl 27 MG 24HR Extended Release Oral Tablet, BX Rating	PSN	3d1f5aff-5d39-496c-b5ed-7f3c70ec641c	32
2001566	methylphenidate HCl 36 MG 24HR Extended Release Oral Tablet, BX Rating	PSN	3d1f5aff-5d39-496c-b5ed-7f3c70ec641c	32
2001568	methylphenidate HCl 54 MG 24HR Extended Release Oral Tablet, BX Rating	PSN	3d1f5aff-5d39-496c-b5ed-7f3c70ec641c	32
2001564	BX Rating 24 HR methylphenidate hydrochloride 18 MG Extended Release Oral Tablet	SCD	3d1f5aff-5d39-496c-b5ed-7f3c70ec641c	32
2001565	BX Rating 24 HR methylphenidate hydrochloride 27 MG Extended Release Oral Tablet	SCD	3d1f5aff-5d39-496c-b5ed-7f3c70ec641c	32
2001566	BX Rating 24 HR methylphenidate hydrochloride 36 MG Extended Release Oral Tablet	SCD	3d1f5aff-5d39-496c-b5ed-7f3c70ec641c	32
2001568	BX Rating 24 HR methylphenidate hydrochloride 54 MG Extended Release Oral Tablet	SCD	3d1f5aff-5d39-496c-b5ed-7f3c70ec641c	32
2001564	methylphenidate HCl 18 MG 24HR Extended Release Oral Tablet, BX Rating	SY	3d1f5aff-5d39-496c-b5ed-7f3c70ec641c	32
2001565	methylphenidate HCl 27 MG 24HR Extended Release Oral Tablet, BX Rating	SY	3d1f5aff-5d39-496c-b5ed-7f3c70ec641c	32
2001566	methylphenidate HCl 36 MG 24HR Extended Release Oral Tablet, BX Rating	SY	3d1f5aff-5d39-496c-b5ed-7f3c70ec641c	32
2001568	methylphenidate HCl 54 MG 24HR Extended Release Oral Tablet, BX Rating	SY	3d1f5aff-5d39-496c-b5ed-7f3c70ec641c	32

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
62175-313-37	62175031337	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-313-37)	2013-09-23	0000-00-00	No	No	Current