Home NDC 0406-9907 ANAFRANIL
Product NDC 0406-9907
11-digit product format 004069907
Labeler code 0406
Product ID 0406-9907_07af3867-7f3e-4e1c-8100-ad276cb6185f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clomipramine hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler SpecGx LLC
Application NDA019906
Marketing category NDA
Marketing start 1989-12-29
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 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 ANAFRANIL
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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857297 Internal RxNorm lookup 857299 Internal RxNorm lookup 857301 Internal RxNorm lookup 857303 Internal RxNorm lookup 857305 Internal RxNorm lookup 857307 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 0406-9907-03 ANAFRANIL 30 in 1 BOTTLE CAPSULE 30 22
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLOMIPRAMINE HYDROCHLORIDE ACTIVE INGREDIENT 2LXW0L6GWJ ANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.] 11 CLOMIPRAMINE ACTIVE MOIETY NUV44L116D ANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.] 11 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L ANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.] 11 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.] 11 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.] 11 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.] 11 GELATIN INACTIVE INGREDIENT 2G86QN327L ANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.] 11 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.] 11 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.] 11 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0406-9907 ANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [SPECGX LLC] 22 Current NDC, Legacy NDC, 1 package rows 20241204_4074b555-7635-41a9-809d-fae3b3610059.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 0406-9907-03 00406990703 30 CAPSULE in 1 BOTTLE (0406-9907-03) 30 capsule 1989-12-29 0000-00-00 No No Current