Methylphenidate Hydrochloride

Product NDC: 0406-1144
11-digit product format: 004061144
Labeler code: 0406
Product ID: 0406-1144_3c286d0f-d6c0-47f5-af8b-9a744477a11f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylphenidate Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: SpecGx LLC
Application: ANDA040300
Marketing category: ANDA
Marketing start: 1998-11-27
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 10 mg/1
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 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A040300-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27
A040300-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27
A040300-003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A040300-001	AB
A040300-002	AB
A040300-003	AB

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 · 126 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
2026-08-18 06:07:40	2026-07	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040300-002	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1998-11-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040300-003	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1998-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040300-001	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	1998-11-27	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040300-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040300-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040300-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040300-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040300-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040300-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040300-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040300-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040300-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040300-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040300-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040300-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040300-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040300-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040300-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040300-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040300-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040300-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040300-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040300-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040300-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040300-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040300-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040300-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040300-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040300-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040300-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040300-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040300-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040300-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040300-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040300-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040300-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040300-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040300-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040300-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040300-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040300-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040300-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040300-001	AB	1	`1e350fbaab3a…`

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/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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1091150	Internal RxNorm lookup
1091392	Internal RxNorm lookup
1091497	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
981a2ad8-33f7-4678-9162-9df9685bd4a6	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
0406-1144-01	Methylphenidate Hydrochloride	100 in 1 BOTTLE	TABLET	100		44
0406-1144-10	Methylphenidate Hydrochloride	1000 in 1 BOTTLE	TABLET	1000		44

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0406-1144-01	EA - Each	0406-1144	9862d294-5b0c-46f3-bba6-ac3003caf166	1	2012-07-24
0406-1144-10	EA - Each	0406-1144	bb5d8118-ab3a-4051-b1b4-1b467f89f356	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHYLPHENIDATE HYDROCHLORIDE	ACTIVE INGREDIENT	4B3SC438HI	METHYLPHENIDATE HYDROCHLORIDE TABLET METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	29
METHYLPHENIDATE	ACTIVE MOIETY	207ZZ9QZ49	METHYLPHENIDATE HYDROCHLORIDE TABLET METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	29
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METHYLPHENIDATE HYDROCHLORIDE TABLET METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	29
HYPROMELLOSE 2208 (15000 MPA.S)	INACTIVE INGREDIENT	Z78RG6M2N2	METHYLPHENIDATE HYDROCHLORIDE TABLET METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	29
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METHYLPHENIDATE HYDROCHLORIDE TABLET METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	29
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METHYLPHENIDATE HYDROCHLORIDE TABLET METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	29
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	METHYLPHENIDATE HYDROCHLORIDE TABLET METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	29
METHYLPHENIDATE HYDROCHLORIDE	ACTIVE INGREDIENT	4B3SC438HI	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
METHYLPHENIDATE	ACTIVE MOIETY	207ZZ9QZ49	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0406-1144	METHYLPHENIDATE HYDROCHLORIDE TABLET [SPECGX LLC]	44	Current NDC, Legacy NDC, 2 package rows	20240724_981a2ad8-33f7-4678-9162-9df9685bd4a6.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	American Health Packaging	eb9b7377-d918-43fb-8e82-d14c85ed64a8	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040300 application number: ANDA040300
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	SpecGx LLC	981a2ad8-33f7-4678-9162-9df9685bd4a6	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040300 application number: ANDA040300 ndc (product): 0406-1144

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
1091150	methylphenidate HCl 10 MG Oral Tablet	PSN	981a2ad8-33f7-4678-9162-9df9685bd4a6	44
1091392	methylphenidate HCl 20 MG Oral Tablet	PSN	981a2ad8-33f7-4678-9162-9df9685bd4a6	44
1091497	methylphenidate HCl 5 MG Oral Tablet	PSN	981a2ad8-33f7-4678-9162-9df9685bd4a6	44
1091150	methylphenidate hydrochloride 10 MG Oral Tablet	SCD	981a2ad8-33f7-4678-9162-9df9685bd4a6	44
1091392	methylphenidate hydrochloride 20 MG Oral Tablet	SCD	981a2ad8-33f7-4678-9162-9df9685bd4a6	44
1091497	methylphenidate hydrochloride 5 MG Oral Tablet	SCD	981a2ad8-33f7-4678-9162-9df9685bd4a6	44
1091150	methylphenidate HCl 10 MG Oral Tablet	PSN	eb9b7377-d918-43fb-8e82-d14c85ed64a8	11
1091497	methylphenidate HCl 5 MG Oral Tablet	PSN	eb9b7377-d918-43fb-8e82-d14c85ed64a8	11
1091150	methylphenidate hydrochloride 10 MG Oral Tablet	SCD	eb9b7377-d918-43fb-8e82-d14c85ed64a8	11
1091497	methylphenidate hydrochloride 5 MG Oral Tablet	SCD	eb9b7377-d918-43fb-8e82-d14c85ed64a8	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0406-1144-01	00406114401	100 TABLET in 1 BOTTLE (0406-1144-01)	100 tablet	1998-11-27	0000-00-00	No	No	Current
0406-1144-10	00406114410	1000 TABLET in 1 BOTTLE (0406-1144-10)	1000 tablet	1998-11-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylphenidate Hydrochloride	American Health Packaging	2025-10-22	HUMAN PRESCRIPTION DRUG LABEL	11
Methylphenidate Hydrochloride	SpecGx LLC	2023-10-01	HUMAN PRESCRIPTION DRUG LABEL	44