Imipramine Pamoate

Product NDC: 70518-4730
Requested package NDC: 70518-4730-0
11-digit product format: 705184730
Labeler code: 70518
Product ID: 70518-4730_59799493-0088-734e-e063-6394a90a67ed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Imipramine Pamoate
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA090444
Marketing category: ANDA
Marketing start: 2026-08-20
Substance: IMIPRAMINE PAMOATE
Active strength: 75 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090444-001	IMIPRAMINE PAMOATE	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16
A090444-002	IMIPRAMINE PAMOATE	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16
A090444-003	IMIPRAMINE PAMOATE	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16
A090444-004	IMIPRAMINE PAMOATE	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090444-001	AB
A090444-002	AB
A090444-003	AB
A090444-004	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 · 172 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	A090444-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090444-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090444-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090444-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090444-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090444-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090444-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090444-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090444-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090444-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090444-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090444-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090444-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090444-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090444-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090444-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090444-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090444-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090444-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090444-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090444-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090444-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090444-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090444-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090444-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090444-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090444-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090444-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090444-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090444-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090444-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090444-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090444-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090444-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090444-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090444-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090444-001	IMIPRAMINE PAMOATE	EQ 75MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090444-002	IMIPRAMINE PAMOATE	EQ 100MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090444-003	IMIPRAMINE PAMOATE	EQ 125MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090444-004	IMIPRAMINE PAMOATE	EQ 150MG HYDROCHLORIDE	CAPSULE / ORAL	AB	2010-04-16	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A090444-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090444-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090444-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090444-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090444-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090444-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090444-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090444-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090444-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090444-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090444-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090444-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090444-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090444-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090444-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090444-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090444-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090444-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090444-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090444-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090444-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090444-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090444-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090444-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090444-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090444-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090444-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090444-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090444-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090444-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090444-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090444-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090444-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090444-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090444-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090444-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090444-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090444-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090444-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090444-004	AB	1	`5bbf6a4d5a75…`

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: Imipramine Pamoate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IMIPRAMINE PAMOATE	75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MC34P30298	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
835572	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
76f412fd-f476-40c6-8aa7-9abced75c3e8	Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Imipramine Pamoate	IMIPRAMINE PAMOATE	REMEDYREPACK INC.	76f412fd-f476-40c6-8aa7-9abced75c3e8	2026-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090444 application number: ANDA090444 ndc (package): 70518-4730-0 ndc (product): 70518-4730 ndc11 (package): 70518473000
Imipramine Pamoate	IMIPRAMINE PAMOATE	Lupin Pharmaceuticals, Inc.	d1dde497-1889-4424-af18-da7ca6459cf3	2026-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090444 application number: ANDA090444

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MC34P30298	IMIPRAMINE PAMOATE	10075-24-8	IMIPRAMINE PAMOATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4730-0	70518473000	50 POUCH in 1 BOX (70518-4730-0) / 1 CAPSULE in 1 POUCH (70518-4730-1)	50 pouch	2026-08-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Imipramine Pamoate Capsules USP For oral administration Rx only	REMEDYREPACK INC.	2026-08-20	HUMAN PRESCRIPTION DRUG LABEL	1