Premarin

Product NDC: 0046-0749
11-digit product format: 000460749
Labeler code: 0046
Product ID: 0046-0749_97a59d56-720c-42fd-86b7-00ad93752452
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CONJUGATED ESTROGENS
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Application: NDA010402
Marketing category: NDA
Marketing start: 1956-12-01
Substance: ESTROGENS, CONJUGATED
Active strength: 25 mg/5mL
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
N010402-001	PREMARIN	ESTROGENS, CONJUGATED	25MG/VIAL	INJECTABLE / INJECTION		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	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N010402-001	PREMARIN	25MG/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESTROGENS, CONJUGATED	25 mg/5mL

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
211975	Internal RxNorm lookup
310203	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
87e2da8d-432c-4ed5-67a1-dc26294b2295	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
0046-0749-05	Premarin	5 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	5		22
0046-0749-05	Premarin	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0046-0749-05	EA - Each	0046-0749	99bc58ba-fd6e-4cd8-bb09-11fd246c4937	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESTROGENS, CONJUGATED	ACTIVE INGREDIENT	IU5QR144QX	PREMARIN (CONJUGATED ESTROGENS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	12
ESTROGENS, CONJUGATED	ACTIVE MOIETY	IU5QR144QX	PREMARIN (CONJUGATED ESTROGENS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	12
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREMARIN (CONJUGATED ESTROGENS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	12
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	PREMARIN (CONJUGATED ESTROGENS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0046-0749	PREMARIN (CONJUGATED ESTROGENS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]	21	Current NDC, Legacy NDC, 2 package rows	20240308_87e2da8d-432c-4ed5-67a1-dc26294b2295.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	CONJUGATED ESTROGENS	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	87e2da8d-432c-4ed5-67a1-dc26294b2295	2025-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 010402 application number: NDA010402 ndc (product): 0046-0749

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
310203	estrogens, conjugated 25 MG Injection	PSN	87e2da8d-432c-4ed5-67a1-dc26294b2295	22
211975	Premarin Intravenous 25 MG Injection	PSN	87e2da8d-432c-4ed5-67a1-dc26294b2295	22
211975	estrogens, conjugated (USP) 25 MG Injection [Premarin]	SBD	87e2da8d-432c-4ed5-67a1-dc26294b2295	22
310203	estrogens, conjugated (USP) 25 MG Injection	SCD	87e2da8d-432c-4ed5-67a1-dc26294b2295	22
211975	Premarin Intravenous 25 MG Injection	SY	87e2da8d-432c-4ed5-67a1-dc26294b2295	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0046-0749-05	00046074905	1 VIAL in 1 CARTON (0046-0749-05) / 5 mL in 1 VIAL	1 vial	1956-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Premarin ® Intravenous (conjugated estrogens, USP) for injection	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. \| Pfizer Canada ULC \| Pfizer Ireland Pharmaceuticals Unlimited Company	2025-05-30	HUMAN PRESCRIPTION DRUG LABEL	22