Home NDC 0054-0275 Imipramine Pamoate
Product NDC 0054-0275
11-digit product format 000540275
Labeler code 0054
Product ID 0054-0275_9c97ff7a-cee1-4c19-a52e-3f22798834fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Imipramine Pamoate
Dosage form CAPSULE
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc
Application ANDA091099
Marketing category ANDA
Marketing start 2010-04-19
Substance IMIPRAMINE PAMOATE
Active strength 125 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091099-001 IMIPRAMINE PAMOATE IMIPRAMINE PAMOATE EQ 75MG HYDROCHLORIDE CAPSULE / ORAL AB RS 2010-04-16 A091099-002 IMIPRAMINE PAMOATE IMIPRAMINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL AB 2010-04-16 A091099-003 IMIPRAMINE PAMOATE IMIPRAMINE PAMOATE EQ 125MG HYDROCHLORIDE CAPSULE / ORAL AB 2010-04-16 A091099-004 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.
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 · 164 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A091099-001 IMIPRAMINE PAMOATE EQ 75MG HYDROCHLORIDE CAPSULE / ORAL AB RS 2010-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091099-002 IMIPRAMINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL AB 2010-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091099-003 IMIPRAMINE PAMOATE EQ 125MG HYDROCHLORIDE CAPSULE / ORAL AB 2010-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091099-004 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 A091099-001 IMIPRAMINE PAMOATE EQ 75MG HYDROCHLORIDE CAPSULE / ORAL AB RS 2010-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091099-002 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 A091099-003 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 A091099-004 IMIPRAMINE PAMOATE EQ 150MG HYDROCHLORIDE CAPSULE / ORAL AB 2010-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091099-001 IMIPRAMINE PAMOATE EQ 75MG HYDROCHLORIDE CAPSULE / ORAL AB RS 2010-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091099-002 IMIPRAMINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL AB 2010-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091099-003 IMIPRAMINE PAMOATE EQ 125MG HYDROCHLORIDE CAPSULE / ORAL AB 2010-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091099-004 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 A091099-001 IMIPRAMINE PAMOATE EQ 75MG HYDROCHLORIDE CAPSULE / ORAL AB RS 2010-04-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091099-002 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 A091099-003 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 A091099-004 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 A091099-001 IMIPRAMINE PAMOATE EQ 75MG HYDROCHLORIDE CAPSULE / ORAL AB RS 2010-04-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091099-002 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 A091099-003 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 A091099-004 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 A091099-001 IMIPRAMINE PAMOATE EQ 75MG HYDROCHLORIDE CAPSULE / ORAL AB RS 2010-04-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091099-002 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 A091099-003 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 A091099-004 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 A091099-001 IMIPRAMINE PAMOATE EQ 75MG HYDROCHLORIDE CAPSULE / ORAL AB RS 2010-04-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091099-002 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 A091099-003 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 A091099-004 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 A091099-001 IMIPRAMINE PAMOATE EQ 75MG HYDROCHLORIDE CAPSULE / ORAL AB RS 2010-04-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091099-002 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 A091099-003 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 A091099-004 IMIPRAMINE PAMOATE EQ 150MG HYDROCHLORIDE CAPSULE / ORAL AB 2010-04-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091099-001 IMIPRAMINE PAMOATE EQ 75MG HYDROCHLORIDE CAPSULE / ORAL AB RS 2010-04-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091099-002 IMIPRAMINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL AB 2010-04-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091099-003 IMIPRAMINE PAMOATE EQ 125MG HYDROCHLORIDE CAPSULE / ORAL AB 2010-04-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091099-004 IMIPRAMINE PAMOATE EQ 150MG HYDROCHLORIDE CAPSULE / ORAL AB 2010-04-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091099-001 IMIPRAMINE PAMOATE EQ 75MG HYDROCHLORIDE CAPSULE / ORAL AB RS 2010-04-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091099-002 IMIPRAMINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL AB 2010-04-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091099-003 IMIPRAMINE PAMOATE EQ 125MG HYDROCHLORIDE CAPSULE / ORAL AB 2010-04-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091099-004 IMIPRAMINE PAMOATE EQ 150MG HYDROCHLORIDE CAPSULE / ORAL AB 2010-04-16 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Imipramine Pamoate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IMIPRAMINE PAMOATE 125 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 835572 Internal RxNorm lookup 835577 Internal RxNorm lookup 835589 Internal RxNorm lookup 835591 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0054-0275-13 Imipramine Pamoate 30 in 1 BOTTLE CAPSULE 30 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IMIPRAMINE PAMOATE ACTIVE INGREDIENT MC34P30298 IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC] 3 IMIPRAMINE ACTIVE MOIETY OGG85SX4E4 IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC] 3 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC] 3 FERROUS OXIDE INACTIVE INGREDIENT G7036X8B5H IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IMIPRAMINE PAMOATE CAPSULE [ROXANE LABORATORIES, INC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0275 IMIPRAMINE PAMOATE CAPSULE [HIKMA PHARMACEUTICALS USA INC] 8 Current NDC, Legacy NDC, 1 package rows 20250403_6e780825-2a66-41fd-a04c-78fa7c4df05e.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0054-0275-13 00054027513 30 CAPSULE in 1 BOTTLE (0054-0275-13) 30 capsule 2010-04-19 0000-00-00 No No Current