Home NDC 59746-710-30 Clomipramine Hydrochloride
Product NDC 59746-710
Requested package NDC 59746-710-30
11-digit product format 597460710
Labeler code 59746
Product ID 59746-710_e9402f3a-49dc-49d9-8ddf-cd940bfb28a8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clomipramine HCl
Dosage form CAPSULE
Route ORAL
Labeler JUBILANT CADISTA PHARMACEUTICALS INC.
Application ANDA212218
Marketing category ANDA
Marketing start 2019-12-01
Marketing end 0000-00-00
Substance CLOMIPRAMINE HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A212218-001 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2019-10-21 A212218-002 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2019-10-21 A212218-003 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2019-10-21
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.
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 2026-08-01 22:54:32 2026-06 A212218-001 CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE / ORAL AB 2019-10-21 a50c72e98297…2026-08-01 22:54:32 2026-06 A212218-002 CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE / ORAL AB 2019-10-21 a50c72e98297…2026-08-01 22:54:32 2026-06 A212218-003 CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE / ORAL AB 2019-10-21 a50c72e98297…
Observed Orange Book normalized TE history# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 59746-710-01 2025-12-31 C162847 48780-1 2cef2736-6ad0-d83d-e063-dadaa90ab31f Clomipramine Hydrochloride Capsules, USP (25 mg, 50 mg, and 75 mg) Rx Only 59746-710-30 2025-12-31 C162847 48780-1 2cef2736-6ad0-d83d-e063-dadaa90ab31f Clomipramine Hydrochloride Capsules, USP (25 mg, 50 mg, and 75 mg) Rx Only 59746-710-90 2025-12-31 C162847 48780-1 2cef2736-6ad0-d83d-e063-dadaa90ab31f Clomipramine Hydrochloride Capsules, USP (25 mg, 50 mg, and 75 mg) Rx Only 59746-710-01 2025-01-30 C162847 48780-1 2cef2736-6ad0-d83d-e063-dadaa90ab31f Clomipramine Hydrochloride Capsules, USP (25 mg, 50 mg, and 75 mg) Rx Only 59746-710-30 2025-01-30 C162847 48780-1 2cef2736-6ad0-d83d-e063-dadaa90ab31f Clomipramine Hydrochloride Capsules, USP (25 mg, 50 mg, and 75 mg) Rx Only 59746-710-90 2025-01-30 C162847 48780-1 2cef2736-6ad0-d83d-e063-dadaa90ab31f Clomipramine Hydrochloride Capsules, USP (25 mg, 50 mg, and 75 mg) Rx Only
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59746-710 CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HCL) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.] 3 Legacy NDC 20191201_84f5249b-c3e4-4e4a-abb6-d5b3ff6cbf4b.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59746-710-30 59746071030 30 CAPSULE in 1 BOTTLE (59746-710-30) 30 capsule 2019-12-01 0000-00-00 No No Current