Imipramine Hydrochloride

Product NDC: 64380-169
11-digit product format: 643800169
Labeler code: 64380
Product ID: 64380-169_07bb51f0-34dd-43fa-8364-9223e58bdb6c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Imipramine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Strides Pharma Science Limited
Application: ANDA088292
Marketing category: ANDA
Marketing start: 2022-04-11
Substance: IMIPRAMINE HYDROCHLORIDE
Active strength: 10 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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088292-001	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1983-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088292-001	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 2 · 42 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	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088292-001	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1983-10-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A088292-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088292-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088292-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088292-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088292-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088292-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088292-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088292-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088292-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088292-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088292-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088292-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088292-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088292-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088292-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088292-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088292-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088292-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088292-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088292-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088292-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088292-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088292-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088292-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088292-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088292-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088292-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088292-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088292-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088292-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088292-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088292-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088292-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088292-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088292-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088292-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088292-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088292-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088292-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088292-001	AB	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IMIPRAMINE 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
BKE5Q1J60U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
835564	Internal RxNorm lookup
835568	Internal RxNorm lookup
835593	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
51d3b181-0d15-4782-a966-feb137972b18	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a0e0df1b-51aa-4301-873c-732ab0ec1631	Product name	1	20170614
0c52f100-e529-4cfc-bd59-334f3eea0233	Product name	1	20151110

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64380-169-01	Imipramine Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET	100		5
64380-169-02	Imipramine Hydrochloride	1000 in 1 BOTTLE, PLASTIC	TABLET	1000		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64380-169-01	EA - Each	64380-169	a20117a6-3d9a-4270-8bb4-8c04bcdd33fb	1	2022-05-04
64380-169-02	EA - Each	64380-169	5f9c3c3e-0dfe-492e-bec8-54a2e4240dbc	1	2022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64380-169	IMIPRAMINE HYDROCHLORIDE TABLET [STRIDES PHARMA SCIENCE LIMITED]	3	Current NDC, Legacy NDC, 2 package rows	20230530_51d3b181-0d15-4782-a966-feb137972b18.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Strides Pharma Science Limited	51d3b181-0d15-4782-a966-feb137972b18	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088292 application number: ANDA088292 ndc (product): 64380-169

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BKE5Q1J60U	IMIPRAMINE HYDROCHLORIDE	113-52-0	IMIPRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
835593	imipramine HCl 10 MG Oral Tablet	PSN	51d3b181-0d15-4782-a966-feb137972b18	5
835564	imipramine HCl 25 MG Oral Tablet	PSN	51d3b181-0d15-4782-a966-feb137972b18	5
835568	imipramine HCl 50 MG Oral Tablet	PSN	51d3b181-0d15-4782-a966-feb137972b18	5
835593	imipramine hydrochloride 10 MG Oral Tablet	SCD	51d3b181-0d15-4782-a966-feb137972b18	5
835564	imipramine hydrochloride 25 MG Oral Tablet	SCD	51d3b181-0d15-4782-a966-feb137972b18	5
835568	imipramine hydrochloride 50 MG Oral Tablet	SCD	51d3b181-0d15-4782-a966-feb137972b18	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64380-169-01	64380016901	100 TABLET in 1 BOTTLE, PLASTIC (64380-169-01)	100 tablet	2022-04-11	0000-00-00	No	No	Current
64380-169-02	64380016902	1000 TABLET in 1 BOTTLE, PLASTIC (64380-169-02)	1000 tablet	2022-04-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Imipramine Hydrochloride Tablets, USP Rx Only	Strides Pharma Science Limited \| Strides Pharma International AG \| Strides Pharma, Inc	2026-07-01	HUMAN PRESCRIPTION DRUG LABEL	6