Premarin
- Product NDC
- 0046-1104
- 11-digit product format
- 000461104
- Labeler code
- 0046
- Product ID
- 0046-1104_7273b788-92aa-4d38-8812-33edaf21bd42
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- estrogens, conjugated
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- Application
- NDA004782
- Marketing category
- NDA
- Marketing start
- 2004-09-01
- Substance
- ESTROGENS, CONJUGATED
- Active strength
- 1.25 mg/1
- Pharmacologic classes
- Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| 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#
| Application-product | TE code |
|---|---|
| N004782-001 | AB |
| N004782-003 | AB |
| N004782-004 | AB |
| N004782-005 | AB |
| N004782-006 | AB |
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.
| 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 | 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… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N004782-005 | PREMARIN | 0.9MG | TABLET / ORAL | RLD, RS | 1984-01-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N004782-006 | PREMARIN | 0.45MG | TABLET / ORAL | RLD | 2003-07-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N004782-001 | PREMARIN | 1.25MG | TABLET / ORAL | RLD, RS, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N004782-002 | PREMARIN | 2.5MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N004782-003 | PREMARIN | 0.3MG | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N004782-004 | PREMARIN | 0.625MG | TABLET / ORAL | RLD, RS, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N004782-005 | PREMARIN | 0.9MG | TABLET / ORAL | RLD, RS | 1984-01-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N004782-006 | PREMARIN | 0.45MG | TABLET / ORAL | RLD | 2003-07-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N004782-001 | PREMARIN | 1.25MG | TABLET / ORAL | RLD, RS, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N004782-002 | PREMARIN | 2.5MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N004782-003 | PREMARIN | 0.3MG | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N004782-004 | PREMARIN | 0.625MG | TABLET / ORAL | RLD, RS, Approved before 1982 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N004782-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N004782-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N004782-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N004782-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N004782-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N004782-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N004782-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N004782-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N004782-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N004782-006 | AB | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N004782-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N004782-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N004782-004 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N004782-005 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N004782-006 | AB | 1 | a50c72e98297… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Premarin
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ESTROGENS, CONJUGATED | 1.25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| IU5QR144QX | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 150840 | Internal RxNorm lookup |
| 197660 | Internal RxNorm lookup |
| 197661 | Internal RxNorm lookup |
| 197662 | Internal RxNorm lookup |
| 202301 | Internal RxNorm lookup |
| 208513 | Internal RxNorm lookup |
| 208949 | Internal RxNorm lookup |
| 310197 | Internal RxNorm lookup |
| 403849 | Internal RxNorm lookup |
| 404550 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 258e1602-a3cf-4ccc-ca80-73dbbfb812ff | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d95be220-b30e-4165-a12d-f83825b0efb1 | Product name | 1 | 20160111 |
| 882e78d5-69f7-4a43-812f-1c1628241bbc | Product name | 1 | 20150910 |
| 2e1ce74f-4938-37b4-e2b4-cfd7971b45ea | Product name | 1 | 20140508 |
| d90784c3-64a2-2f23-9acd-d948d25bf235 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0046-1104-81 | Premarin | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 36 | |
| 0046-1104-91 | Premarin | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 36 | |
| 0046-1104-91 | Premarin | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 36 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0046-1104-81 | EA - Each | 0046-1104 | a26ec858-dd5a-45d3-a3d6-b59aa53bf05b | 1 | 2012-07-24 |
| 0046-1104-91 | EA - Each | 0046-1104 | 045e5620-93ba-4999-9077-0ceb7d44f25a | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Premarin | ESTROGENS, CONJUGATED | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 258e1602-a3cf-4ccc-ca80-73dbbfb812ff | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | 004782 NDA004782 0046-1104 |
| Conjugated Estrogens | ESTROGENS, CONJUGATED | Prasco Laboratories | ce793f9e-0c20-43e6-9dc0-064e5c82e243 | 2026-02-27 | Boxed warning, Warnings, Adverse reactions | 004782 NDA004782 |
| Premarin | ESTROGENS, CONJUGATED | A-S Medication Solutions | a3b86b85-8923-42ae-aa31-a66a6e090327 | 2025-04-02 | Boxed warning, Warnings, Adverse reactions | 004782 NDA004782 |
| PREMARIN | ESTROGENS, CONJUGATED | A-S Medication Solutions | 2b4dbb7c-4e6d-47c9-b940-fef91f1f4a05 | 2024-02-04 | Boxed warning, Warnings, Adverse reactions | 004782 NDA004782 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197660 | estrogens, conjugated 0.3 MG Oral Tablet | PSN | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 403849 | estrogens, conjugated 0.45 MG Oral Tablet | PSN | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 310197 | estrogens, conjugated 0.625 MG Oral Tablet | PSN | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 197661 | estrogens, conjugated 0.9 MG Oral Tablet | PSN | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 197662 | estrogens, conjugated 1.25 MG Oral Tablet | PSN | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 208513 | PREMARIN 0.3 MG Oral Tablet | PSN | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 404550 | PREMARIN 0.45 MG Oral Tablet | PSN | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 150840 | PREMARIN 0.625 MG Oral Tablet | PSN | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 208949 | PREMARIN 0.9 MG Oral Tablet | PSN | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 202301 | PREMARIN 1.25 MG Oral Tablet | PSN | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 208513 | estrogens, conjugated (USP) 0.3 MG Oral Tablet [Premarin] | SBD | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 404550 | estrogens, conjugated (USP) 0.45 MG Oral Tablet [Premarin] | SBD | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 150840 | estrogens, conjugated (USP) 0.625 MG Oral Tablet [Premarin] | SBD | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 208949 | estrogens, conjugated (USP) 0.9 MG Oral Tablet [Premarin] | SBD | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 202301 | estrogens, conjugated (USP) 1.25 MG Oral Tablet [Premarin] | SBD | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 197660 | estrogens, conjugated (USP) 0.3 MG Oral Tablet | SCD | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 403849 | estrogens, conjugated (USP) 0.45 MG Oral Tablet | SCD | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 310197 | estrogens, conjugated (USP) 0.625 MG Oral Tablet | SCD | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 197661 | estrogens, conjugated (USP) 0.9 MG Oral Tablet | SCD | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 197662 | estrogens, conjugated (USP) 1.25 MG Oral Tablet | SCD | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 310197 | estrogens, conjugated (USP) 625 MCG Oral Tablet | SY | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 208513 | Premarin 0.3 MG Oral Tablet | SY | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 404550 | Premarin 0.45 MG Oral Tablet | SY | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 150840 | Premarin 0.625 MG Oral Tablet | SY | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 208949 | Premarin 0.9 MG Oral Tablet | SY | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
| 202301 | Premarin 1.25 MG Oral Tablet | SY | b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0046-1104-81 | 00046110481 | 100 TABLET, FILM COATED in 1 BOTTLE (0046-1104-81) | 2004-09-01 | 0000-00-00 | No | No | Current | |
| 0046-1104-91 | 00046110491 | 1 BOTTLE in 1 CARTON (0046-1104-91) / 1000 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2004-09-01 | 0000-00-00 | No | No | Current |