Home NDC 16714-851-03 Clomipramine Hydrochloride
Product NDC 16714-851
Requested package NDC 16714-851-03
11-digit product format 167140851
Labeler code 16714
Product ID 16714-851_81294b8f-8cab-4c90-b0b3-c78fb6f80338
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clomipramine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Northstar Rx LLC.
Application ANDA208961
Marketing category ANDA
Marketing start 2018-08-27
Marketing end 2027-06-30
Substance CLOMIPRAMINE HYDROCHLORIDE
Active strength 75 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
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 A208961-001 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 A208961-002 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 A208961-003 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27
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 · 135 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 2026-11-14 07:37:17 2026-10 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208961-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2017-12-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208961-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2017-12-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208961-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2017-12-27 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 135 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 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOMIPRAMINE HYDROCHLORIDE 75 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 16714-851-01 Clomipramine Hydrochloride 30 in 1 BOTTLE CAPSULE 30 3 16714-851-02 Clomipramine Hydrochloride 90 in 1 BOTTLE CAPSULE 90 3 16714-851-03 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 16714-851 CLOMIPRAMINE HYDROCHLORIDE CAPSULE [NORTHSTAR RX LLC.] 3 Current NDC, Legacy NDC, 3 package rows 20221130_b1809cb2-c6a8-451a-b692-506456c4efc3.zip
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 16714-851-03 16714085103 100 CAPSULE in 1 BOTTLE (16714-851-03) 100 capsule 2018-08-27 2027-06-30 No No Current