Maprotiline Hydrochloride

Product NDC: 0378-0060
11-digit product format: 003780060
Labeler code: 0378
Product ID: 0378-0060_4255111c-66ea-4343-9401-7faffde9132a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: maprotiline hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA072285
Marketing category: ANDA
Marketing start: 1988-10-03
Marketing end: 0000-00-00
Substance: MAPROTILINE HYDROCHLORIDE
Active strength: 25 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0378-0060		D	Discontinued by firm		2026-10-12
excluded package	package	0378-0060	0378-0060-01	D	Discontinued by firm		2026-10-12

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	0378-0060-01	`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	0378-0060-01	`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	0378-0060-01	`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	0378-0060-01	`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	0378-0060-01	`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	0378-0060-01	`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	0378-0060-01	`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	0378-0060-01	`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	0378-0060-01	`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	0378-0060-01	`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	0378-0060-01	`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	0378-0060-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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	Approval date
A072285-001	MAPROTILINE HYDROCHLORIDE	MAPROTILINE HYDROCHLORIDE	50MG	TABLET / ORAL	1988-10-03
A072285-002	MAPROTILINE HYDROCHLORIDE	MAPROTILINE HYDROCHLORIDE	25MG	TABLET / ORAL	1988-10-03
A072285-003	MAPROTILINE HYDROCHLORIDE	MAPROTILINE HYDROCHLORIDE	75MG	TABLET / ORAL	1988-10-03

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A072285-001	MAPROTILINE HYDROCHLORIDE	50MG	TABLET / ORAL	1988-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072285-002	MAPROTILINE HYDROCHLORIDE	25MG	TABLET / ORAL	1988-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072285-003	MAPROTILINE HYDROCHLORIDE	75MG	TABLET / ORAL	1988-10-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072285-001	MAPROTILINE HYDROCHLORIDE	50MG	TABLET / ORAL	1988-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072285-002	MAPROTILINE HYDROCHLORIDE	25MG	TABLET / ORAL	1988-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072285-003	MAPROTILINE HYDROCHLORIDE	75MG	TABLET / ORAL	1988-10-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072285-001	MAPROTILINE HYDROCHLORIDE	50MG	TABLET / ORAL	1988-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072285-002	MAPROTILINE HYDROCHLORIDE	25MG	TABLET / ORAL	1988-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072285-003	MAPROTILINE HYDROCHLORIDE	75MG	TABLET / ORAL	1988-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072285-001	MAPROTILINE HYDROCHLORIDE	50MG	TABLET / ORAL	1988-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072285-002	MAPROTILINE HYDROCHLORIDE	25MG	TABLET / ORAL	1988-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072285-003	MAPROTILINE HYDROCHLORIDE	75MG	TABLET / ORAL	1988-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072285-001	MAPROTILINE HYDROCHLORIDE	50MG	TABLET / ORAL	1988-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072285-002	MAPROTILINE HYDROCHLORIDE	25MG	TABLET / ORAL	1988-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072285-003	MAPROTILINE HYDROCHLORIDE	75MG	TABLET / ORAL	1988-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072285-001	MAPROTILINE HYDROCHLORIDE	50MG	TABLET / ORAL	1988-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072285-002	MAPROTILINE HYDROCHLORIDE	25MG	TABLET / ORAL	1988-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072285-003	MAPROTILINE HYDROCHLORIDE	75MG	TABLET / ORAL	1988-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072285-001	MAPROTILINE HYDROCHLORIDE	50MG	TABLET / ORAL	1988-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072285-002	MAPROTILINE HYDROCHLORIDE	25MG	TABLET / ORAL	1988-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072285-003	MAPROTILINE HYDROCHLORIDE	75MG	TABLET / ORAL	1988-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072285-001	MAPROTILINE HYDROCHLORIDE	50MG	TABLET / ORAL	1988-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072285-002	MAPROTILINE HYDROCHLORIDE	25MG	TABLET / ORAL	1988-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072285-003	MAPROTILINE HYDROCHLORIDE	75MG	TABLET / ORAL	1988-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072285-001	MAPROTILINE HYDROCHLORIDE	50MG	TABLET / ORAL	1988-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072285-002	MAPROTILINE HYDROCHLORIDE	25MG	TABLET / ORAL	1988-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072285-003	MAPROTILINE HYDROCHLORIDE	75MG	TABLET / ORAL	1988-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072285-001	MAPROTILINE HYDROCHLORIDE	50MG	TABLET / ORAL	1988-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072285-002	MAPROTILINE HYDROCHLORIDE	25MG	TABLET / ORAL	1988-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072285-003	MAPROTILINE HYDROCHLORIDE	75MG	TABLET / ORAL	1988-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072285-001	MAPROTILINE HYDROCHLORIDE	50MG	TABLET / ORAL	1988-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072285-002	MAPROTILINE HYDROCHLORIDE	25MG	TABLET / ORAL	1988-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072285-003	MAPROTILINE HYDROCHLORIDE	75MG	TABLET / ORAL	1988-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072285-001	MAPROTILINE HYDROCHLORIDE	50MG	TABLET / ORAL	1988-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072285-002	MAPROTILINE HYDROCHLORIDE	25MG	TABLET / ORAL	1988-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072285-003	MAPROTILINE HYDROCHLORIDE	75MG	TABLET / ORAL	1988-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072285-001	MAPROTILINE HYDROCHLORIDE	50MG	TABLET / ORAL	1988-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072285-002	MAPROTILINE HYDROCHLORIDE	25MG	TABLET / ORAL	1988-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072285-003	MAPROTILINE HYDROCHLORIDE	75MG	TABLET / ORAL	1988-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072285-001	MAPROTILINE HYDROCHLORIDE	50MG	TABLET / ORAL	1988-10-03	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0060-01	EA - Each	0378-0060	206050f8-0fbd-4b1e-b205-ccee6838f1f5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MAPROTILINE HYDROCHLORIDE	ACTIVE INGREDIENT	7C8J54PVFI	MAPROTILINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	10
MAPROTILINE	ACTIVE MOIETY	2U1W68TROF	MAPROTILINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MAPROTILINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	10
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MAPROTILINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	10
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MAPROTILINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	10
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MAPROTILINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MAPROTILINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	10
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	MAPROTILINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	10
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	MAPROTILINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MAPROTILINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	10
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MAPROTILINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MAPROTILINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MAPROTILINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	10
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	MAPROTILINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	10

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7C8J54PVFI	MAPROTILINE HYDROCHLORIDE	10347-81-6	MAPROTILINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-0060-01	00378006001	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0060-01)	1988-10-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Maprotiline Hydrochloride - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2014-12-25	HUMAN PRESCRIPTION DRUG LABEL	11