Home DailyMed 153b1627-0fc4-4a2a-a1ae-4e8367dcddc9 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 2013-02-13
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 03:32:15 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 N004782-001 PREMARIN ESTROGENS, CONJUGATED 1.25MG TABLET / ORAL AB RLD, RS, Approved before 1982 N004782-002 PREMARIN ESTROGENS, CONJUGATED 2.5MG TABLET / ORAL Approved before 1982 N004782-003 PREMARIN ESTROGENS, CONJUGATED 0.3MG TABLET / ORAL AB RLD, Approved before 1982 N004782-004 PREMARIN ESTROGENS, CONJUGATED 0.625MG TABLET / ORAL AB RLD, RS, Approved before 1982 N004782-005 PREMARIN ESTROGENS, CONJUGATED 0.9MG TABLET / ORAL AB RLD, RS 1984-01-26 N004782-006 PREMARIN ESTROGENS, CONJUGATED 0.45MG TABLET / ORAL AB RLD 2003-07-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 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 N004782-001 PREMARIN 1.25MG TABLET / ORAL AB RLD, RS, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N004782-002 PREMARIN 2.5MG TABLET / ORAL Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N004782-003 PREMARIN 0.3MG TABLET / ORAL AB RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N004782-004 PREMARIN 0.625MG TABLET / ORAL AB RLD, RS, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N004782-005 PREMARIN 0.9MG TABLET / ORAL AB RLD, RS 1984-01-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N004782-006 PREMARIN 0.45MG TABLET / ORAL AB RLD 2003-07-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N004782-001 PREMARIN 1.25MG TABLET / ORAL AB RLD, RS, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N004782-002 PREMARIN 2.5MG TABLET / ORAL Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N004782-003 PREMARIN 0.3MG TABLET / ORAL AB RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N004782-004 PREMARIN 0.625MG TABLET / ORAL AB RLD, RS, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N004782-005 PREMARIN 0.9MG TABLET / ORAL AB RLD, RS 1984-01-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N004782-006 PREMARIN 0.45MG TABLET / ORAL AB RLD 2003-07-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N004782-001 PREMARIN 1.25MG TABLET / ORAL AB RLD, RS, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N004782-002 PREMARIN 2.5MG TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N004782-003 PREMARIN 0.3MG TABLET / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N004782-004 PREMARIN 0.625MG TABLET / ORAL AB RLD, RS, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N004782-005 PREMARIN 0.9MG TABLET / ORAL AB RLD, RS 1984-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N004782-006 PREMARIN 0.45MG TABLET / ORAL AB RLD 2003-07-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N004782-001 PREMARIN 1.25MG TABLET / ORAL AB RLD, RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N004782-002 PREMARIN 2.5MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N004782-003 PREMARIN 0.3MG TABLET / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N004782-004 PREMARIN 0.625MG TABLET / ORAL AB RLD, RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N004782-005 PREMARIN 0.9MG TABLET / ORAL AB RLD, RS 1984-01-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N004782-006 PREMARIN 0.45MG TABLET / ORAL AB RLD 2003-07-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N004782-001 PREMARIN 1.25MG TABLET / ORAL RLD, RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N004782-002 PREMARIN 2.5MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N004782-003 PREMARIN 0.3MG TABLET / ORAL RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N004782-004 PREMARIN 0.625MG TABLET / ORAL RLD, RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N004782-005 PREMARIN 0.9MG TABLET / ORAL RLD, RS 1984-01-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N004782-006 PREMARIN 0.45MG TABLET / ORAL RLD 2003-07-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N004782-001 PREMARIN 1.25MG TABLET / ORAL RLD, RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N004782-002 PREMARIN 2.5MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N004782-003 PREMARIN 0.3MG TABLET / ORAL RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N004782-004 PREMARIN 0.625MG TABLET / ORAL RLD, RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N004782-005 PREMARIN 0.9MG TABLET / ORAL RLD, RS 1984-01-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N004782-006 PREMARIN 0.45MG TABLET / ORAL RLD 2003-07-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N004782-001 PREMARIN 1.25MG TABLET / ORAL RLD, RS, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N004782-002 PREMARIN 2.5MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N004782-003 PREMARIN 0.3MG TABLET / ORAL RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N004782-004 PREMARIN 0.625MG TABLET / ORAL RLD, RS, Approved before 1982 b8a1b40f171c…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.