Home DailyMed c04c7776-9df8-4287-9e8f-97ffbca4f050 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:35:59 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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SARAFEM FLUOXETINE HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06 N018936-008 SARAFEM FLUOXETINE HYDROCHLORIDE EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2000-07-06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 · 258 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 2026-09-14 22:38:34 2026-08 N018936-001 PROZAC EQ 20MG BASE CAPSULE / ORAL RLD 1987-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018936-003 PROZAC EQ 40MG BASE CAPSULE / ORAL RLD 1999-06-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018936-004 PROZAC EQ 60MG BASE CAPSULE / ORAL 1999-06-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018936-006 PROZAC EQ 10MG BASE CAPSULE / ORAL RLD 1992-12-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-08-18 06:07:40 2026-07 N018936-001 PROZAC EQ 20MG BASE CAPSULE / ORAL RLD 1987-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018936-003 PROZAC EQ 40MG BASE CAPSULE / ORAL RLD 1999-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018936-004 PROZAC EQ 60MG BASE CAPSULE / ORAL 1999-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018936-006 PROZAC EQ 10MG BASE CAPSULE / ORAL RLD 1992-12-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 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 caaa826d4ba7…2026-08-18 06:07:40 2026-07 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 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.