Home NDC 0406-8808 CLOMIPRAMINE HYDROCHLORIDE
Product NDC 0406-8808
11-digit product format 004068808
Labeler code 0406
Product ID 0406-8808_f7da2c91-cd58-46c3-b716-846a454cfb07
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clomipramine hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler SpecGx LLC
Application NDA019906
Marketing category NDA
Marketing start 2015-06-01
Substance CLOMIPRAMINE HYDROCHLORIDE
Active strength 75 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 42 .
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 N019906-001 ANAFRANIL CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB RLD, RS 1989-12-29 N019906-002 ANAFRANIL CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB RLD 1989-12-29 N019906-003 ANAFRANIL CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB RLD 1989-12-29
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 · 126 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 2026-08-18 06:07:40 2026-07 N019906-001 ANAFRANIL 25MG CAPSULE / ORAL AB RLD, RS 1989-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019906-002 ANAFRANIL 50MG CAPSULE / ORAL AB RLD 1989-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019906-003 ANAFRANIL 75MG CAPSULE / ORAL AB RLD 1989-12-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019906-001 ANAFRANIL 25MG CAPSULE / ORAL AB RLD, RS 1989-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019906-002 ANAFRANIL 50MG CAPSULE / ORAL AB RLD 1989-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019906-003 ANAFRANIL 75MG CAPSULE / ORAL AB RLD 1989-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019906-001 ANAFRANIL 25MG CAPSULE / ORAL AB RLD, RS 1989-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019906-002 ANAFRANIL 50MG CAPSULE / ORAL AB RLD 1989-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019906-003 ANAFRANIL 75MG CAPSULE / ORAL AB RLD 1989-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019906-001 ANAFRANIL 25MG CAPSULE / ORAL AB RLD, RS 1989-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019906-002 ANAFRANIL 50MG CAPSULE / ORAL AB RLD 1989-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019906-003 ANAFRANIL 75MG CAPSULE / ORAL AB RLD 1989-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019906-001 ANAFRANIL 25MG CAPSULE / ORAL AB RLD, RS 1989-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019906-002 ANAFRANIL 50MG CAPSULE / ORAL AB RLD 1989-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019906-003 ANAFRANIL 75MG CAPSULE / ORAL AB RLD 1989-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019906-001 ANAFRANIL 25MG CAPSULE / ORAL AB RLD, RS 1989-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019906-002 ANAFRANIL 50MG CAPSULE / ORAL AB RLD 1989-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019906-003 ANAFRANIL 75MG CAPSULE / ORAL AB RLD 1989-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019906-001 ANAFRANIL 25MG CAPSULE / ORAL AB RLD, RS 1989-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019906-002 ANAFRANIL 50MG CAPSULE / ORAL AB RLD 1989-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019906-003 ANAFRANIL 75MG CAPSULE / ORAL AB RLD 1989-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019906-001 ANAFRANIL 25MG CAPSULE / ORAL AB RLD, RS 1989-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019906-002 ANAFRANIL 50MG CAPSULE / ORAL AB RLD 1989-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019906-003 ANAFRANIL 75MG CAPSULE / ORAL AB RLD 1989-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019906-001 ANAFRANIL 25MG CAPSULE / ORAL AB RLD, RS 1989-12-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019906-002 ANAFRANIL 50MG CAPSULE / ORAL AB RLD 1989-12-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019906-003 ANAFRANIL 75MG CAPSULE / ORAL AB RLD 1989-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019906-001 ANAFRANIL 25MG CAPSULE / ORAL AB RLD, RS 1989-12-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019906-002 ANAFRANIL 50MG CAPSULE / ORAL AB RLD 1989-12-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019906-003 ANAFRANIL 75MG CAPSULE / ORAL AB RLD 1989-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019906-001 ANAFRANIL 25MG CAPSULE / ORAL AB RLD, RS 1989-12-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019906-002 ANAFRANIL 50MG CAPSULE / ORAL AB RLD 1989-12-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019906-003 ANAFRANIL 75MG CAPSULE / ORAL AB RLD 1989-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019906-001 ANAFRANIL 25MG CAPSULE / ORAL AB RLD, RS 1989-12-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019906-002 ANAFRANIL 50MG CAPSULE / ORAL AB RLD 1989-12-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019906-003 ANAFRANIL 75MG CAPSULE / ORAL AB RLD 1989-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019906-001 ANAFRANIL 25MG CAPSULE / ORAL AB RLD, RS 1989-12-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019906-002 ANAFRANIL 50MG CAPSULE / ORAL AB RLD 1989-12-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019906-003 ANAFRANIL 75MG CAPSULE / ORAL AB RLD 1989-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019906-001 ANAFRANIL 25MG CAPSULE / ORAL AB RLD, RS 1989-12-29 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
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 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 0406-8808-01 CLOMIPRAMINE HYDROCHLORIDE 100 in 1 BOTTLE CAPSULE 100 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLOMIPRAMINE HYDROCHLORIDE ACTIVE INGREDIENT 2LXW0L6GWJ CLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.] 2 CLOMIPRAMINE ACTIVE MOIETY NUV44L116D CLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.] 2 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L CLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L CLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T CLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH CLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0406-8808 CLOMIPRAMINE HYDROCHLORIDE CAPSULE [SPECGX LLC] 15 Current NDC, Legacy NDC, 1 package rows 20241128_d7cee3fa-d05c-4702-8f75-f446627bdb49.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 0406-8808-01 00406880801 100 CAPSULE in 1 BOTTLE (0406-8808-01) 100 capsule 2015-06-01 0000-00-00 No No Current