DESIPRAMINE HYDROCHLORIDE

Product NDC: 50742-112
11-digit product format: 507420112
Labeler code: 50742
Product ID: 50742-112_7a0e5dd9-7456-4774-b529-ce9d5627b654
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: desipramine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Ingenus Pharmaceuticals, LLC
Application: ANDA204963
Marketing category: ANDA
Marketing start: 2018-09-19
Substance: DESIPRAMINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
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 1.

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
A204963-001	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-12-26
A204963-002	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-12-26
A204963-003	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-12-26
A204963-004	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-12-26
A204963-005	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-26
A204963-006	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-12-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204963-001	AB
A204963-002	AB
A204963-003	AB
A204963-004	AB
A204963-005	AB
A204963-006	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 · 246 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
2026-02-19 14:30 UTC	2026-02	A204963-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204963-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204963-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204963-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204963-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204963-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204963-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204963-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204963-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204963-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204963-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204963-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204963-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-12-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204963-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-12-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204963-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-12-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204963-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-12-26	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204963-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204963-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204963-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204963-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204963-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204963-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204963-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204963-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204963-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204963-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204963-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204963-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204963-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204963-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204963-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204963-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204963-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204963-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204963-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204963-004	AB	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: DESIPRAMINE HYDROCHLORIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DESIPRAMINE 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
1Y58DO4MY1	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1099288	Internal RxNorm lookup
1099292	Internal RxNorm lookup
1099296	Internal RxNorm lookup
1099300	Internal RxNorm lookup
1099304	Internal RxNorm lookup
1099316	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
7280f157-3fff-41c5-b3f4-510b8bacdaba	Available on FDA.report

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
50742-112-01	DESIPRAMINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET	100		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50742-112-01	EA - Each	50742-112	661c5271-3c44-463c-a26a-e921733f4bd0	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50742-112	DESIPRAMINE HYDROCHLORIDE TABLET [INGENUS PHARMACEUTICALS, LLC]	11	Current NDC, Legacy NDC, 1 package rows	20230627_7280f157-3fff-41c5-b3f4-510b8bacdaba.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	REMEDYREPACK INC.	dc1601be-e16a-411f-b9b8-01c51abb2441	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204963 application number: ANDA204963
DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Ingenus Pharmaceuticals, LLC	7280f157-3fff-41c5-b3f4-510b8bacdaba	2025-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204963 application number: ANDA204963 ndc (product): 50742-112
Desipramine HCL	DESIPRAMINE HCL	Direct_Rx	ed9d2290-9ad9-ecff-e053-2a95a90a5fd6	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204963 application number: ANDA204963

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1Y58DO4MY1	DESIPRAMINE HYDROCHLORIDE	58-28-6	DESIPRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1099288	desipramine HCl 10 MG Oral Tablet	PSN	7280f157-3fff-41c5-b3f4-510b8bacdaba	12
1099292	desipramine HCl 100 MG Oral Tablet	PSN	7280f157-3fff-41c5-b3f4-510b8bacdaba	12
1099296	desipramine HCl 150 MG Oral Tablet	PSN	7280f157-3fff-41c5-b3f4-510b8bacdaba	12
1099300	desipramine HCl 25 MG Oral Tablet	PSN	7280f157-3fff-41c5-b3f4-510b8bacdaba	12
1099304	desipramine HCl 50 MG Oral Tablet	PSN	7280f157-3fff-41c5-b3f4-510b8bacdaba	12
1099316	desipramine HCl 75 MG Oral Tablet	PSN	7280f157-3fff-41c5-b3f4-510b8bacdaba	12
1099288	desipramine hydrochloride 10 MG Oral Tablet	SCD	7280f157-3fff-41c5-b3f4-510b8bacdaba	12
1099292	desipramine hydrochloride 100 MG Oral Tablet	SCD	7280f157-3fff-41c5-b3f4-510b8bacdaba	12
1099296	desipramine hydrochloride 150 MG Oral Tablet	SCD	7280f157-3fff-41c5-b3f4-510b8bacdaba	12
1099300	desipramine hydrochloride 25 MG Oral Tablet	SCD	7280f157-3fff-41c5-b3f4-510b8bacdaba	12
1099304	desipramine hydrochloride 50 MG Oral Tablet	SCD	7280f157-3fff-41c5-b3f4-510b8bacdaba	12
1099316	desipramine hydrochloride 75 MG Oral Tablet	SCD	7280f157-3fff-41c5-b3f4-510b8bacdaba	12
1099288	desipramine HCl 10 MG Oral Tablet	PSN	ed9d2290-9ad9-ecff-e053-2a95a90a5fd6	2
1099288	desipramine hydrochloride 10 MG Oral Tablet	SCD	ed9d2290-9ad9-ecff-e053-2a95a90a5fd6	2
1099288	desipramine HCl 10 MG Oral Tablet	PSN	dc1601be-e16a-411f-b9b8-01c51abb2441	1
1099288	desipramine hydrochloride 10 MG Oral Tablet	SCD	dc1601be-e16a-411f-b9b8-01c51abb2441	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50742-112-01	50742011201	100 TABLET in 1 BOTTLE (50742-112-01)	100 tablet	2018-09-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Desipramine Hydrochloride Tablets, USP	REMEDYREPACK INC.	2026-04-28	HUMAN PRESCRIPTION DRUG LABEL	1
Desipramine Hydrochloride Tablets, USP	Ingenus Pharmaceuticals, LLC \| Novast Laboratories , Ltd.	2025-07-30	HUMAN PRESCRIPTION DRUG LABEL	12
Desipramine HCL	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	2