Home NDC 67046-171 Escitalopram
Product NDC 67046-171
11-digit product format 670460171
Labeler code 67046
Product ID 67046-171_5a084ea4-cafd-ffed-e053-2991aa0aa0d9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Escitalopram
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Contract Pharmacy Services-PA
Application ANDA076765
Marketing category ANDA
Marketing start 2017-09-25
Marketing end 0000-00-00
Substance ESCITALOPRAM OXALATE
Active strength 10 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 4 · 189 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A076765-001 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 A076765-002 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 A076765-003 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14
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 · 132 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 2026-10-15 13:18:30 2026-09 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076765-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL 2012-03-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076765-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL 2012-03-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076765-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL 2012-03-14 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 51 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67046-171-07 Escitalopram 7 in 1 BLISTER PACK TABLET, FILM COATED 7 1 67046-171-14 Escitalopram 14 in 1 BLISTER PACK TABLET, FILM COATED 14 1 67046-171-15 Escitalopram 15 in 1 BLISTER PACK TABLET, FILM COATED 15 1 67046-171-20 Escitalopram 20 in 1 BLISTER PACK TABLET, FILM COATED 20 1 67046-171-21 Escitalopram 21 in 1 BLISTER PACK TABLET, FILM COATED 21 1 67046-171-28 Escitalopram 28 in 1 BLISTER PACK TABLET, FILM COATED 28 1 67046-171-30 Escitalopram 30 in 1 BLISTER PACK TABLET, FILM COATED 30 1 67046-171-60 Escitalopram 60 in 1 BLISTER PACK TABLET, FILM COATED 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67046-171 ESCITALOPRAM TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA] 1 Legacy NDC, 8 package rows 20170925_5a084ea4-cafc-ffed-e053-2991aa0aa0d9.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 67046-171-07 67046017107 7 in 1 BLISTER PACK Historical 67046-171-14 67046017114 14 in 1 BLISTER PACK Historical 67046-171-15 67046017115 15 in 1 BLISTER PACK Historical 67046-171-20 67046017120 20 in 1 BLISTER PACK Historical 67046-171-21 67046017121 21 in 1 BLISTER PACK Historical 67046-171-28 67046017128 28 in 1 BLISTER PACK Historical 67046-171-30 67046017130 30 in 1 BLISTER PACK Historical 67046-171-60 67046017160 60 in 1 BLISTER PACK Historical