Premarin

Product NDC: 0046-1103
11-digit product format: 000461103
Labeler code: 0046
Product ID: 0046-1103_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: 2006-01-01
Substance: ESTROGENS, CONJUGATED
Active strength: .9 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

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
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.

Application-product, TE code table
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.

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	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 table
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 table
Ingredient	Strength
ESTROGENS, CONJUGATED	.9 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
IU5QR144QX	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
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#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
258e1602-a3cf-4ccc-ca80-73dbbfb812ff	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
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 table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0046-1103-81	Premarin	100 in 1 BOTTLE	TABLET, FILM COATED	100		36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0046-1103-81	EA - Each	0046-1103	9125c986-1340-43e6-9a32-9b1cf377c5d7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESTROGENS, CONJUGATED	ACTIVE INGREDIENT	IU5QR144QX	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	21
ESTROGENS, CONJUGATED	ACTIVE MOIETY	IU5QR144QX	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	21
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	21
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	21
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	21
D&C RED NO. 7	INACTIVE INGREDIENT	ECW0LZ41X8	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	21
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	21
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	21
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	21
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	21
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	21
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	21
HYPROMELLOSE 2208 (15000 MPA.S)	INACTIVE INGREDIENT	Z78RG6M2N2	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	21
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	21
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	21
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	21
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	21
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	21
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	21
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	21
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	21
TRIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	91D9GV0Z28	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	21
ESTROGENS, CONJUGATED	ACTIVE INGREDIENT	IU5QR144QX	PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
ESTROGENS, CONJUGATED	ACTIVE MOIETY	IU5QR144QX	PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
D&C RED NO. 7	INACTIVE INGREDIENT	ECW0LZ41X8	PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
HYPROMELLOSE 2208 (15000 MPA.S)	INACTIVE INGREDIENT	Z78RG6M2N2	PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
TRIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	91D9GV0Z28	PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0046-1103	PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]	35	Current NDC, Legacy NDC, 1 package rows	20250508_258e1602-a3cf-4ccc-ca80-73dbbfb812ff.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
Premarin	ESTROGENS, CONJUGATED	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	258e1602-a3cf-4ccc-ca80-73dbbfb812ff	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 004782 application number: NDA004782 ndc (product): 0046-1103
Conjugated Estrogens	ESTROGENS, CONJUGATED	Prasco Laboratories	ce793f9e-0c20-43e6-9dc0-064e5c82e243	2026-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 004782 application number: NDA004782
Premarin	ESTROGENS, CONJUGATED	A-S Medication Solutions	a3b86b85-8923-42ae-aa31-a66a6e090327	2025-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 004782 application number: NDA004782
PREMARIN	ESTROGENS, CONJUGATED	A-S Medication Solutions	2b4dbb7c-4e6d-47c9-b940-fef91f1f4a05	2024-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 004782 application number: NDA004782

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IU5QR144QX	ESTROGENS, CONJUGATED	12126-59-9	ESTROGENS, CONJUGATED

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
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 table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0046-1103-81	00046110381	100 TABLET, FILM COATED in 1 BOTTLE (0046-1103-81)	2006-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Premarin	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. \| Pfizer Italia S.r.l. \| Pfizer Canada ULC \| Pfizer Ireland Pharmaceuticals Unlimited Company	2026-06-04	HUMAN PRESCRIPTION DRUG LABEL	37
Premarin - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2014-05-08	HUMAN PRESCRIPTION DRUG LABEL	3