Methylphenidate Hydrochloride

Product NDC: 0527-3310
11-digit product format: 005273310
Labeler code: 0527
Product ID: 0527-3310_b80118d9-003b-41b9-b156-e10cfb84712d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylphenidate Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA211918
Marketing category: ANDA
Marketing start: 2019-04-24
Marketing end: 0000-00-00
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 18 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0527-3310-37	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0527-3310-37	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0527-3310-37	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0527-3310-37	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0527-3310-37	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0527-3310-37	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0527-3310-37	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0527-3310-37	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0527-3310-37	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0527-3310-37	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0527-3310-37	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0527-3310-37	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A211918-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24
A211918-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24
A211918-003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24
A211918-004	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211918-001	AB
A211918-002	AB
A211918-003	AB
A211918-004	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 5 · 168 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	A211918-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211918-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211918-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211918-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211918-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211918-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211918-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211918-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211918-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211918-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211918-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211918-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211918-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211918-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211918-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211918-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211918-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211918-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211918-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211918-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211918-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211918-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211918-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211918-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211918-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211918-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211918-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211918-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211918-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211918-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211918-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211918-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211918-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211918-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211918-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211918-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211918-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211918-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211918-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211918-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-24	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A211918-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211918-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211918-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211918-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211918-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211918-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211918-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211918-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211918-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211918-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211918-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211918-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211918-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211918-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211918-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211918-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211918-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211918-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211918-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211918-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211918-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211918-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211918-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211918-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211918-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211918-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211918-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211918-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211918-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211918-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211918-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211918-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211918-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211918-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211918-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211918-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211918-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211918-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211918-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211918-004	AB	1	`d8e5a09893c0…`

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	18 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
1091155	Internal RxNorm lookup
1091170	Internal RxNorm lookup
1091185	Internal RxNorm lookup
1091210	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
44737c1d-fe75-409e-8a58-591696d3d7aa	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
0527-3310-37	Methylphenidate Hydrochloride	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-3310-37	EA - Each	0527-3310	aa3157f4-1a3b-4e19-b47a-1d885d68c62b	1	2019-06-19

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Lannett Company, Inc.	44737c1d-fe75-409e-8a58-591696d3d7aa	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211918 application number: ANDA211918 ndc (product): 0527-3310

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
1091155	methylphenidate HCl 18 MG 24HR Extended Release Oral Tablet	PSN	44737c1d-fe75-409e-8a58-591696d3d7aa	13
1091170	methylphenidate HCl 27 MG 24HR Extended Release Oral Tablet	PSN	44737c1d-fe75-409e-8a58-591696d3d7aa	13
1091185	methylphenidate HCl 36 MG 24HR Extended Release Oral Tablet	PSN	44737c1d-fe75-409e-8a58-591696d3d7aa	13
1091210	methylphenidate HCl 54 MG 24HR Extended Release Oral Tablet	PSN	44737c1d-fe75-409e-8a58-591696d3d7aa	13
1091155	24 HR methylphenidate hydrochloride 18 MG Extended Release Oral Tablet	SCD	44737c1d-fe75-409e-8a58-591696d3d7aa	13
1091170	24 HR methylphenidate hydrochloride 27 MG Extended Release Oral Tablet	SCD	44737c1d-fe75-409e-8a58-591696d3d7aa	13
1091185	24 HR methylphenidate hydrochloride 36 MG Extended Release Oral Tablet	SCD	44737c1d-fe75-409e-8a58-591696d3d7aa	13
1091210	24 HR methylphenidate hydrochloride 54 MG Extended Release Oral Tablet	SCD	44737c1d-fe75-409e-8a58-591696d3d7aa	13
1091155	methylphenidate hydrochloride 18 MG 24 HR Extended Release Oral Tablet	SY	44737c1d-fe75-409e-8a58-591696d3d7aa	13
1091170	methylphenidate hydrochloride 27 MG 24 HR Extended Release Oral Tablet	SY	44737c1d-fe75-409e-8a58-591696d3d7aa	13
1091185	methylphenidate hydrochloride 36 MG 24 HR Extended Release Oral Tablet	SY	44737c1d-fe75-409e-8a58-591696d3d7aa	13
1091210	methylphenidate hydrochloride 54 MG 24 HR Extended Release Oral Tablet	SY	44737c1d-fe75-409e-8a58-591696d3d7aa	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0527-3310-37	00527331037	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-3310-37)	2019-04-24	0000-00-00	No	No	Current