Premarin

Product NDC: 0046-0872
11-digit product format: 000460872
Labeler code: 0046
Product ID: 0046-0872_94b7195e-3ce2-4e04-a814-9b63add4896e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: conjugated estrogens
Dosage form: CREAM
Route: VAGINAL
Labeler: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Application: NDA020216
Marketing category: NDA
Marketing start: 1978-11-01
Substance: ESTROGENS, CONJUGATED
Active strength: .625 mg/g
Pharmacologic classes: Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020216-001	PREMARIN	ESTROGENS, CONJUGATED	0.625MG/GM	CREAM / TOPICAL, VAGINAL		RLD, RS, Approved before 1982

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020216-001	PREMARIN	0.625MG/GM	CREAM / TOPICAL, VAGINAL	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Premarin
Brand name suffix: Vaginal
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESTROGENS, CONJUGATED	.625 mg/g

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
688240	Internal RxNorm lookup
688242	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
96609623-528e-4aba-cabe-7254aed816d5	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	SPL version
0046-0872-04	PremarinVaginal	1 in 1 CARTON	CREAM	1	33
0046-0872-04	PremarinVaginal	4 g in 1 TUBE, WITH APPLICATOR	CREAM	4	33
0046-0872-21	PremarinVaginal	1 in 1 CARTON	CREAM	1	33
0046-0872-21	PremarinVaginal	30 g in 1 TUBE, WITH APPLICATOR	CREAM	30	33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0046-0872-21	GM - Gram	0046-0872	c9a3ccb5-df04-4261-907b-63460cf8b52e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESTROGENS, CONJUGATED	ACTIVE INGREDIENT	IU5QR144QX	PREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	19
ESTROGENS, CONJUGATED	ACTIVE MOIETY	IU5QR144QX	PREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	19
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	PREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	19
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	PREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	19
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	19
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	PREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	19
METHYL STEARATE	INACTIVE INGREDIENT	8D4NXF3ZH7	PREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	19
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	PREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	19
PROPYLENE GLYCOL MONOPALMITOSTEARATE	INACTIVE INGREDIENT	F76354LMGR	PREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	19
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	19
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	PREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0046-0872	PREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]	32	Current NDC, Legacy NDC, 4 package rows	20250507_96609623-528e-4aba-cabe-7254aed816d5.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Premarin Vaginal	CONJUGATED ESTROGENS	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	96609623-528e-4aba-cabe-7254aed816d5	2025-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020216 application number: NDA020216 ndc (product): 0046-0872

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
688240	estrogens, conjugated 0.625 MG/GM Vaginal Cream	PSN	96609623-528e-4aba-cabe-7254aed816d5	33
688242	premarin 0.625 MG/GM Vaginal Cream	PSN	96609623-528e-4aba-cabe-7254aed816d5	33
688242	estrogens, conjugated (USP) 0.625 MG/ML Vaginal Cream [Premarin]	SBD	96609623-528e-4aba-cabe-7254aed816d5	33
688240	estrogens, conjugated (USP) 0.625 MG/ML Vaginal Cream	SCD	96609623-528e-4aba-cabe-7254aed816d5	33
688240	estrogens, conjugated (USP) 0.0625 % Vaginal Cream	SY	96609623-528e-4aba-cabe-7254aed816d5	33
688242	Premarin 0.625 MG per GM Vaginal Cream	SY	96609623-528e-4aba-cabe-7254aed816d5	33
688242	Premarin 0.625 MG/ML Vaginal Cream	SY	96609623-528e-4aba-cabe-7254aed816d5	33

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0046-0872-04	00046087204	1 TUBE, WITH APPLICATOR in 1 CARTON (0046-0872-04) / 4 g in 1 TUBE, WITH APPLICATOR	1978-11-01	0000-00-00	No	No	Current
0046-0872-21	00046087221	1 TUBE, WITH APPLICATOR in 1 CARTON (0046-0872-21) / 30 g in 1 TUBE, WITH APPLICATOR	1978-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Premarin Vaginal	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. \| Pfizer Canada ULC \| Pfizer Ireland Pharmaceuticals Unlimited Company	2025-05-30	HUMAN PRESCRIPTION DRUG LABEL	33