Desipramine Hydrochloride

Product NDC: 69238-1055
11-digit product format: 692381055
Labeler code: 69238
Product ID: 69238-1055_6ea5e8b8-b492-440b-9e38-4ef1c0b46ee2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desipramine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA208105
Marketing category: ANDA
Marketing start: 2016-03-21
Substance: DESIPRAMINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
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 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208105-001	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2016-03-17
A208105-002	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2016-03-17
A208105-003	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2016-03-17
A208105-004	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-03-17
A208105-005	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-03-17
A208105-006	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-03-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A208105-001	AB
A208105-002	AB
A208105-003	AB
A208105-004	AB
A208105-005	AB
A208105-006	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 7 · 258 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	A208105-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2016-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208105-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2016-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208105-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2016-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208105-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208105-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208105-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-03-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208105-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2016-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208105-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2016-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208105-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2016-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208105-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208105-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208105-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208105-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2016-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208105-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2016-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208105-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2016-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208105-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208105-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208105-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208105-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2016-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208105-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2016-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208105-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2016-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208105-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208105-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208105-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208105-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2016-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208105-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2016-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208105-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2016-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208105-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208105-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208105-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208105-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2016-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208105-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2016-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208105-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2016-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208105-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208105-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208105-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208105-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2016-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208105-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2016-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208105-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2016-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208105-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-03-17	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208105-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208105-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208105-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208105-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208105-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208105-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208105-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208105-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208105-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208105-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208105-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208105-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208105-005	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208105-006	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208105-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208105-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208105-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208105-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208105-005	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208105-006	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208105-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208105-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208105-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208105-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208105-005	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208105-006	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208105-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208105-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208105-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208105-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208105-005	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208105-006	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208105-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208105-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208105-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208105-004	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208105-005	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208105-006	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208105-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208105-002	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DESIPRAMINE HYDROCHLORIDE	25 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bda46dda-4ebd-3e63-0043-123c9d173af2	Product name	6	20220125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69238-1055-1	Desipramine Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100		13
69238-1055-3	Desipramine Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69238-1055-1	EA - Each	69238-1055	120b8b06-788d-4818-acd3-2c823054c766	1	2016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-1055	DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]	11	Current NDC, Legacy NDC, 2 package rows	20241218_a3b4b25d-0ddb-4531-badb-f1ba3168ac07.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1Y58DO4MY1	DESIPRAMINE HYDROCHLORIDE	58-28-6	DESIPRAMINE HYDROCHLORIDE
TG537D343B	DESIPRAMINE	50-47-5	Desipramine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1099288	desipramine HCl 10 MG Oral Tablet	PSN	a3b4b25d-0ddb-4531-badb-f1ba3168ac07	13
1099292	desipramine HCl 100 MG Oral Tablet	PSN	a3b4b25d-0ddb-4531-badb-f1ba3168ac07	13
1099296	desipramine HCl 150 MG Oral Tablet	PSN	a3b4b25d-0ddb-4531-badb-f1ba3168ac07	13
1099300	desipramine HCl 25 MG Oral Tablet	PSN	a3b4b25d-0ddb-4531-badb-f1ba3168ac07	13
1099304	desipramine HCl 50 MG Oral Tablet	PSN	a3b4b25d-0ddb-4531-badb-f1ba3168ac07	13
1099316	desipramine HCl 75 MG Oral Tablet	PSN	a3b4b25d-0ddb-4531-badb-f1ba3168ac07	13
1099288	desipramine hydrochloride 10 MG Oral Tablet	SCD	a3b4b25d-0ddb-4531-badb-f1ba3168ac07	13
1099292	desipramine hydrochloride 100 MG Oral Tablet	SCD	a3b4b25d-0ddb-4531-badb-f1ba3168ac07	13
1099296	desipramine hydrochloride 150 MG Oral Tablet	SCD	a3b4b25d-0ddb-4531-badb-f1ba3168ac07	13
1099300	desipramine hydrochloride 25 MG Oral Tablet	SCD	a3b4b25d-0ddb-4531-badb-f1ba3168ac07	13
1099304	desipramine hydrochloride 50 MG Oral Tablet	SCD	a3b4b25d-0ddb-4531-badb-f1ba3168ac07	13
1099316	desipramine hydrochloride 75 MG Oral Tablet	SCD	a3b4b25d-0ddb-4531-badb-f1ba3168ac07	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69238-1055-1	69238105501	100 TABLET, FILM COATED in 1 BOTTLE (69238-1055-1)	2016-03-21	0000-00-00	No	No	Current
69238-1055-3	69238105503	30 TABLET, FILM COATED in 1 BOTTLE (69238-1055-3)	2016-03-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Desipramine Hydrochloride Tablets, USP (10 mg, 25 mg, 50 mg, 75 mg, 100 mg & 150 mg) Rx only	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals Private Limited	2026-09-17	HUMAN PRESCRIPTION DRUG LABEL	14