Home NDC 0777-3105-30 Prozac
Product NDC 0777-3105
Requested package NDC 0777-3105-30
11-digit product format 007773105
Labeler code 0777
Product ID 0777-3105_e49a90e3-e7da-4377-8736-ebe9f53c3097
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluoxetine hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Dista Products Company
Application NDA018936
Marketing category NDA
Marketing start 1988-02-01
Marketing end 2027-06-16
Substance FLUOXETINE HYDROCHLORIDE
Active strength 20 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
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 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018936-001 PROZAC FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL RLD 1987-12-29 N018936-003 PROZAC FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL RLD 1999-06-15 N018936-004 PROZAC FLUOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL 1999-06-15 N018936-006 PROZAC FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL RLD 1992-12-23 N018936-007 SARAFEM FLUOXETINE HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 N018936-008 SARAFEM FLUOXETINE HYDROCHLORIDE EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06
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 7 · 246 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 2026-02-19 14:30 UTC 2026-02 N018936-001 PROZAC EQ 20MG BASE CAPSULE / ORAL AB1 RLD 1987-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018936-003 PROZAC EQ 40MG BASE CAPSULE / ORAL AB RLD, RS 1999-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018936-004 PROZAC EQ 60MG BASE CAPSULE / ORAL 1999-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018936-006 PROZAC EQ 10MG BASE CAPSULE / ORAL AB1 RLD 1992-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018936-007 SARAFEM EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018936-008 SARAFEM EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018936-001 PROZAC EQ 20MG BASE CAPSULE / ORAL AB1 RLD 1987-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018936-003 PROZAC EQ 40MG BASE CAPSULE / ORAL AB RLD, RS 1999-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018936-004 PROZAC EQ 60MG BASE CAPSULE / ORAL 1999-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018936-006 PROZAC EQ 10MG BASE CAPSULE / ORAL AB1 RLD 1992-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018936-007 SARAFEM EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018936-008 SARAFEM EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018936-001 PROZAC EQ 20MG BASE CAPSULE / ORAL AB1 RLD 1987-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018936-003 PROZAC EQ 40MG BASE CAPSULE / ORAL AB RLD, RS 1999-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018936-004 PROZAC EQ 60MG BASE CAPSULE / ORAL 1999-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018936-006 PROZAC EQ 10MG BASE CAPSULE / ORAL AB1 RLD 1992-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018936-007 SARAFEM EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018936-008 SARAFEM EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018936-001 PROZAC EQ 20MG BASE CAPSULE / ORAL AB1 RLD 1987-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018936-003 PROZAC EQ 40MG BASE CAPSULE / ORAL AB RLD, RS 1999-06-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018936-004 PROZAC EQ 60MG BASE CAPSULE / ORAL 1999-06-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018936-006 PROZAC EQ 10MG BASE CAPSULE / ORAL AB1 RLD 1992-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018936-007 SARAFEM EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018936-008 SARAFEM EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018936-001 PROZAC EQ 20MG BASE CAPSULE / ORAL AB1 RLD 1987-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018936-003 PROZAC EQ 40MG BASE CAPSULE / ORAL AB RLD, RS 1999-06-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018936-004 PROZAC EQ 60MG BASE CAPSULE / ORAL 1999-06-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018936-006 PROZAC EQ 10MG BASE CAPSULE / ORAL AB1 RLD 1992-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018936-007 SARAFEM EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018936-008 SARAFEM EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018936-001 PROZAC EQ 20MG BASE CAPSULE / ORAL AB1 RLD 1987-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018936-003 PROZAC EQ 40MG BASE CAPSULE / ORAL AB RLD, RS 1999-06-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018936-004 PROZAC EQ 60MG BASE CAPSULE / ORAL 1999-06-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018936-006 PROZAC EQ 10MG BASE CAPSULE / ORAL AB1 RLD 1992-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018936-007 SARAFEM EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018936-008 SARAFEM EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018936-001 PROZAC EQ 20MG BASE CAPSULE / ORAL AB1 RLD 1987-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018936-003 PROZAC EQ 40MG BASE CAPSULE / ORAL AB RLD, RS 1999-06-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018936-004 PROZAC EQ 60MG BASE CAPSULE / ORAL 1999-06-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018936-006 PROZAC EQ 10MG BASE CAPSULE / ORAL AB1 RLD 1992-12-23 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Prozac Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOXETINE HYDROCHLORIDE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination I9W7N6B1KJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 104849 Internal RxNorm lookup 205535 Internal RxNorm lookup 261287 Internal RxNorm lookup 310384 Internal RxNorm lookup 310385 Internal RxNorm lookup 313989 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 0777-3105-02 Prozac 100 in 1 BOTTLE CAPSULE 100 59 0777-3105-30 Prozac 30 in 1 BOTTLE CAPSULE 30 59
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0777-3105 PROZAC (FLUOXETINE HYDROCHLORIDE) CAPSULE [DISTA PRODUCTS COMPANY] 58 Current NDC, Legacy NDC, 2 package rows 20241211_c88f33ed-6dfb-4c5e-bc01-d8e36dd97299.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 0777-3105-30 00777310530 30 CAPSULE in 1 BOTTLE (0777-3105-30) 30 capsule 1988-02-01 2027-05-27 No No Current