Home NDC 71205-912-11 Clomipramine Hydrochloride
Product NDC 71205-912
Requested package NDC 71205-912-11
11-digit product format 712050912
Labeler code 71205
Product ID 71205-912_be10b430-6ed9-4241-b6d9-818846e80839
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clomipramine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Proficient Rx LP
Application ANDA211364
Marketing category ANDA
Marketing start 2020-03-10
Substance CLOMIPRAMINE HYDROCHLORIDE
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211364-001 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2020-02-07 A211364-002 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2020-02-07 A211364-003 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2020-02-07
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 3 · 117 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 A211364-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2020-02-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211364-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2020-02-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211364-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2020-02-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211364-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2020-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211364-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2020-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211364-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2020-02-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211364-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2020-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211364-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2020-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211364-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2020-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211364-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2020-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211364-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2020-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211364-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2020-02-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211364-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2020-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211364-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2020-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211364-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2020-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211364-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2020-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211364-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2020-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211364-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2020-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211364-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2020-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211364-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2020-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211364-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2020-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211364-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2020-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211364-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2020-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211364-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2020-02-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211364-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2020-02-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211364-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2020-02-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211364-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2020-02-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211364-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2020-02-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211364-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2020-02-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211364-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2020-02-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211364-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2020-02-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211364-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2020-02-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211364-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2020-02-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211364-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2020-02-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211364-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2020-02-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211364-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2020-02-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211364-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2020-02-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211364-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2020-02-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211364-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2020-02-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211364-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2020-02-07 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 117 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 2027-12-31 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 71205-912-00 Clomipramine Hydrochloride 100 in 1 BOTTLE CAPSULE 100 2 71205-912-11 Clomipramine Hydrochloride 1000 in 1 BOTTLE CAPSULE 1000 2 71205-912-30 Clomipramine Hydrochloride 30 in 1 BOTTLE CAPSULE 30 2 71205-912-55 Clomipramine Hydrochloride 500 in 1 BOTTLE CAPSULE 500 2 71205-912-60 Clomipramine Hydrochloride 60 in 1 BOTTLE CAPSULE 60 2 71205-912-90 Clomipramine Hydrochloride 90 in 1 BOTTLE CAPSULE 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-912 CLOMIPRAMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP] 2 Current NDC, Legacy NDC, 6 package rows 20220415_ff9ed80e-d692-494f-9741-a9af30fa5000.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 · 2 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 71205-912-11 71205091211 1000 CAPSULE in 1 BOTTLE (71205-912-11) 1000 capsule 2021-07-16 0000-00-00 No No Current