Methylphenidate Hydrochloride

Product NDC: 16714-127
Requested package NDC: 16714-127-01
11-digit product format: 167140127
Labeler code: 16714
Product ID: 16714-127_0708b572-6b5d-4f9e-9183-1b694e6ac44f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylphenidate Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Northstar Rx LLC
Application: ANDA211009
Marketing category: ANDA
Marketing start: 2019-10-09
Marketing end: 0000-00-00
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: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	16714-127	16714-127-01	D	Discontinued by firm		2026-09-14

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 · 12 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A211009-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03
A211009-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03
A211009-003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03
A211009-004	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211009-001	AB
A211009-002	AB
A211009-003	AB
A211009-004	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
2026-09-14 22:38:34	2026-08	A211009-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211009-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211009-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211009-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211009-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211009-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211009-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211009-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211009-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211009-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211009-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211009-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211009-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211009-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211009-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211009-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211009-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211009-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211009-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211009-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211009-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211009-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211009-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211009-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211009-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211009-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211009-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211009-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211009-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211009-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211009-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211009-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211009-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211009-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211009-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211009-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211009-001	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211009-002	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211009-003	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211009-004	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-03	`5bbf6a4d5a75…`

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
2026-09-14 22:38:34	2026-08	A211009-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211009-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211009-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211009-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211009-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211009-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211009-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211009-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211009-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211009-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211009-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211009-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211009-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211009-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211009-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211009-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211009-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211009-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211009-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211009-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211009-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211009-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211009-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211009-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211009-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211009-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211009-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211009-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211009-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211009-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211009-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211009-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211009-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211009-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211009-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211009-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211009-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211009-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211009-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211009-004	AB	1	`5bbf6a4d5a75…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-127-01	EA - Each	16714-127	f451fa62-f3f5-487a-8c22-4215d4d8a06c	1	2020-01-03

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	American Health Packaging	f6581305-cd1e-4171-8c1b-e184c7bde033	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211009 application number: ANDA211009
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	b9af3104-172d-4975-9301-b9fe7db9ef12	2021-08-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211009 application number: ANDA211009
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc.	b07150db-fd99-4400-bb83-b3a7544a917a	2021-08-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211009 application number: ANDA211009

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-127-01	16714012701	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-127-01)	2019-10-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylphenidate Hydrochloride	Northstar Rx LLC \| Ascent Pharmaceuticals, Inc.	2021-08-16	HUMAN PRESCRIPTION DRUG LABEL	2