Home NDC 60505-0101 PAROXETINE
Product NDC 60505-0101
11-digit product format 605050101
Labeler code 60505
Product ID 60505-0101_372affaa-7ff0-8369-d124-358a79da4bbe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name paroxetine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Apotex Corp.
Application ANDA075356
Marketing category ANDA
Marketing start 2003-09-08
Substance PAROXETINE HYDROCHLORIDE ANHYDROUS
Active strength 40 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 1 · 36 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075356-001 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 A075356-002 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 A075356-003 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 A075356-004 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 176 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 A075356-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075356-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075356-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075356-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 A075356-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075356-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075356-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075356-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075356-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075356-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075356-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075356-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075356-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075356-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075356-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075356-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075356-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075356-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075356-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075356-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075356-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075356-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075356-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075356-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075356-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075356-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075356-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075356-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075356-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075356-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075356-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075356-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075356-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075356-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075356-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075356-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075356-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2003-07-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075356-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2003-07-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075356-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2003-07-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075356-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2003-07-30 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 5 · 176 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base PAROXETINE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PAROXETINE HYDROCHLORIDE ANHYDROUS 40 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-0101-1 PAROXETINE 30 in 1 BOTTLE TABLET, FILM COATED 30 25 60505-0101-2 PAROXETINE 100 in 1 BOTTLE TABLET, FILM COATED 100 25 60505-0101-4 PAROXETINE 1000 in 1 BOTTLE TABLET, FILM COATED 1000 25 60505-0101-5 PAROXETINE 10 in 1 BLISTER PACK TABLET, FILM COATED 10 25 60505-0101-5 PAROXETINE 10 in 1 CARTON TABLET, FILM COATED 10 25 60505-0101-7 PAROXETINE 7000 in 1 BOTTLE TABLET, FILM COATED 7000 25 60505-0101-9 PAROXETINE 90 in 1 BOTTLE TABLET, FILM COATED 90 25
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PAROXETINE HYDROCHLORIDE ANHYDROUS ACTIVE INGREDIENT 3I3T11UD2S PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.] 11 PAROXETINE ACTIVE MOIETY 41VRH5220H PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.] 11 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.] 11 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.] 11 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.] 11 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.] 11 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.] 11 PAROXETINE HYDROCHLORIDE ANHYDROUS ACTIVE INGREDIENT 3I3T11UD2S PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 PAROXETINE ACTIVE MOIETY 41VRH5220H PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 PAROXETINE HYDROCHLORIDE ANHYDROUS ACTIVE INGREDIENT 3I3T11UD2S PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 PAROXETINE ACTIVE MOIETY 41VRH5220H PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 4 PAROXETINE HYDROCHLORIDE ACTIVE INGREDIENT 3I3T11UD2S PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 PAROXETINE HYDROCHLORIDE ANHYDROUS ACTIVE INGREDIENT 3I3T11UD2S PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 PAROXETINE ACTIVE MOIETY 41VRH5220H PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 PAROXETINE ACTIVE MOIETY 41VRH5220H PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-0101 PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.] 24 Current NDC, Legacy NDC, 7 package rows 20250411_08320ea3-8f93-6f04-5d1c-f69af3eb5a81.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PAROXETINE PAROXETINE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 4d3b4536-7900-223c-e063-6294a90a3d60 2026-03-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075356 application number: ANDA075356 PAROXETINE PAROXETINE HYDROCHLORIDE Cardinal Health 107, LLC 333dfd07-61f0-4b86-b4b5-b04adf64e49f 2025-08-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075356 application number: ANDA075356 PAROXETINE PAROXETINE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 1801246b-02c3-430f-932a-b18cb0d13d1d 2018-11-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075356 application number: ANDA075356 PAROXETINE PAROXETINE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC a7128be7-7023-40c4-aa64-29d52145ae31 2018-10-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075356 application number: ANDA075356
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 60505-0101-1 60505010101 30 TABLET, FILM COATED in 1 BOTTLE (60505-0101-1) 2003-09-08 0000-00-00 No No Current 60505-0101-2 60505010102 100 TABLET, FILM COATED in 1 BOTTLE (60505-0101-2) 2003-09-08 0000-00-00 No No Current 60505-0101-4 60505010104 1000 TABLET, FILM COATED in 1 BOTTLE (60505-0101-4) 2003-09-08 0000-00-00 No No Current 60505-0101-5 60505010105 10 BLISTER PACK in 1 CARTON (60505-0101-5) > 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2003-09-08 0000-00-00 No No Current 60505-0101-7 60505010107 7000 TABLET, FILM COATED in 1 BOTTLE (60505-0101-7) 2003-09-08 0000-00-00 No No Current 60505-0101-9 60505010109 90 TABLET, FILM COATED in 1 BOTTLE (60505-0101-9) 2003-09-08 0000-00-00 No No Current