Home NDC 51407-758 CLOMIPRAMINE HYDROCHLORIDE
Product NDC 51407-758
11-digit product format 514070758
Labeler code 51407
Product ID 51407-758_369e10d3-9839-496f-e063-6294a90aeae7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clomipramine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA074694
Marketing category ANDA
Marketing start 1996-12-31
Substance CLOMIPRAMINE HYDROCHLORIDE
Active strength 50 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 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074694-001 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 1996-12-31 A074694-002 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 1996-12-31 A074694-003 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 1996-12-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 129 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 2026-09-14 22:38:34 2026-08 A074694-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 1996-12-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074694-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 1996-12-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074694-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 1996-12-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074694-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 1996-12-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074694-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 1996-12-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074694-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 1996-12-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074694-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 1996-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074694-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 1996-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074694-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 1996-12-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074694-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 1996-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074694-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 1996-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074694-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 1996-12-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074694-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 1996-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074694-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 1996-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074694-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 1996-12-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074694-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 1996-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074694-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 1996-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074694-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 1996-12-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074694-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 1996-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074694-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 1996-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074694-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 1996-12-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074694-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 1996-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074694-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 1996-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074694-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 1996-12-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074694-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 1996-12-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074694-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 1996-12-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074694-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 1996-12-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074694-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 1996-12-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074694-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 1996-12-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074694-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 1996-12-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074694-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 1996-12-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074694-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 1996-12-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074694-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 1996-12-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074694-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 1996-12-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074694-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 1996-12-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074694-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 1996-12-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074694-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 1996-12-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074694-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 1996-12-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074694-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 1996-12-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074694-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 1996-12-31 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
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 CLOMIPRAMINE HYDROCHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOMIPRAMINE HYDROCHLORIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2LXW0L6GWJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857297 Internal RxNorm lookup 857301 Internal RxNorm lookup 857305 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 51407-758-01 CLOMIPRAMINE HYDROCHLORIDE 100 in 1 BOTTLE CAPSULE 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51407-758 CLOMIPRAMINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 Current NDC, 1 package rows 20241228_fa2eb38c-b155-0d53-e053-6294a90a1d29.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE Major Pharmaceuticals eff91018-5a5e-4426-96ae-71ecd82273b7 2025-06-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074694 application number: ANDA074694 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE Golden State Medical Supply, Inc. fa2eb38c-b155-0d53-e053-6294a90a1d29 2025-06-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074694 application number: ANDA074694 ndc (product): 51407-758 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE Sun Pharmaceutical Industries, Inc. db752dbd-be41-4cdd-8a13-ed1ff9ef7461 2025-05-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074694 application number: ANDA074694 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE American Health Packaging 1809bcb4-5fcc-45ca-986a-4fa5edcd4b5e 2024-10-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074694 application number: ANDA074694
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51407-758-01 51407075801 100 CAPSULE in 1 BOTTLE (51407-758-01) 100 capsule 2023-04-25 No No Current