Home NDC 52427-691 citalopram
Product NDC 52427-691
11-digit product format 524270691
Labeler code 52427
Product ID 52427-691_0bb9dfa0-f842-cf8c-cc79-79a14d75d446
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name citalopram
Dosage form CAPSULE
Route ORAL
Labeler Almatica Pharma LLC
Application NDA215428
Marketing category NDA
Marketing start 2022-01-31
Substance CITALOPRAM HYDROBROMIDE
Active strength 30 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215428-001 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL AB RLD, RS 2022-01-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N215428-001 AB
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 2026-02-19 14:30 UTC 2026-02 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL RLD, RS 2022-01-31 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215428-001 CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE / ORAL AB RLD, RS 2022-01-31 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215428-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base citalopram
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CITALOPRAM HYDROBROMIDE 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination I1E9D14F36 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2591786 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 52427-691-30 citalopram 30 in 1 BOTTLE CAPSULE 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52427-691 CITALOPRAM CAPSULE [ALMATICA PHARMA LLC] 3 Current NDC, Legacy NDC, 1 package rows 20241010_2f815b0c-6da7-cb61-e89c-7de628092d0d.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 · 1 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 52427-691-30 52427069130 30 CAPSULE in 1 BOTTLE (52427-691-30) 30 capsule 2022-03-01 0000-00-00 No No Current