FDA.reportPublic FDA data

Prempro

Product NDC
0046-1108
11-digit product format
000461108
Labeler code
0046
Product ID
0046-1108_cce04608-5f9f-434f-b4ab-d5c19847095a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
conjugated estrogens and medroxyprogesterone acetate
Dosage form
TABLET, SUGAR COATED
Route
ORAL
Labeler
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Application
NDA020527
Marketing category
NDA
Marketing start
2012-12-03
Substance
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
Active strength
.625; 5 mg/1; mg/1
Pharmacologic classes
Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS], Progesterone Congeners [CS], Progestin [EPC]
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020527-001PREMPROESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE0.625MG;2.5MGTABLET / ORAL-28RLD, RS1995-11-17
N020527-002PREMPHASE 14/14ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE0.625MG,0.625MG;N/A,5MGTABLET / ORAL-28RLD, RS1995-11-17
N020527-003PREMPROESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE0.625MG;5MGTABLET / ORAL-28RLD, RS1998-01-09
N020527-004PREMPROESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE0.45MG;1.5MGTABLET / ORAL-28RLD, RS2003-03-12
N020527-005PREMPROESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE0.3MG;1.5MGTABLET / ORAL-28RLD, RS2003-06-04

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 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020527-001PREMPRO0.625MG;2.5MGTABLET / ORAL-28RLD, RS1995-11-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020527-002PREMPHASE 14/140.625MG,0.625MG;N/A,5MGTABLET / ORAL-28RLD, RS1995-11-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020527-003PREMPRO0.625MG;5MGTABLET / ORAL-28RLD, RS1998-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020527-004PREMPRO0.45MG;1.5MGTABLET / ORAL-28RLD, RS2003-03-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020527-005PREMPRO0.3MG;1.5MGTABLET / ORAL-28RLD, RS2003-06-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020527-001PREMPRO0.625MG;2.5MGTABLET / ORAL-28RLD, RS1995-11-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020527-002PREMPHASE 14/140.625MG,0.625MG;N/A,5MGTABLET / ORAL-28RLD, RS1995-11-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020527-003PREMPRO0.625MG;5MGTABLET / ORAL-28RLD, RS1998-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020527-004PREMPRO0.45MG;1.5MGTABLET / ORAL-28RLD, RS2003-03-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020527-005PREMPRO0.3MG;1.5MGTABLET / ORAL-28RLD, RS2003-06-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020527-001PREMPRO0.625MG;2.5MGTABLET / ORAL-28RLD, RS1995-11-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020527-002PREMPHASE 14/140.625MG,0.625MG;N/A,5MGTABLET / ORAL-28RLD, RS1995-11-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020527-003PREMPRO0.625MG;5MGTABLET / ORAL-28RLD, RS1998-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020527-004PREMPRO0.45MG;1.5MGTABLET / ORAL-28RLD, RS2003-03-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020527-005PREMPRO0.3MG;1.5MGTABLET / ORAL-28RLD, RS2003-06-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020527-001PREMPRO0.625MG;2.5MGTABLET / ORAL-28RLD, RS1995-11-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020527-002PREMPHASE 14/140.625MG,0.625MG;N/A,5MGTABLET / ORAL-28RLD, RS1995-11-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020527-003PREMPRO0.625MG;5MGTABLET / ORAL-28RLD, RS1998-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020527-004PREMPRO0.45MG;1.5MGTABLET / ORAL-28RLD, RS2003-03-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020527-005PREMPRO0.3MG;1.5MGTABLET / ORAL-28RLD, RS2003-06-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020527-001PREMPRO0.625MG;2.5MGTABLET / ORAL-28RLD, RS1995-11-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020527-002PREMPHASE 14/140.625MG,0.625MG;N/A,5MGTABLET / ORAL-28RLD, RS1995-11-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020527-003PREMPRO0.625MG;5MGTABLET / ORAL-28RLD, RS1998-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020527-004PREMPRO0.45MG;1.5MGTABLET / ORAL-28RLD, RS2003-03-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020527-005PREMPRO0.3MG;1.5MGTABLET / ORAL-28RLD, RS2003-06-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020527-001PREMPRO0.625MG;2.5MGTABLET / ORAL-28RLD, RS1995-11-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020527-002PREMPHASE 14/140.625MG,0.625MG;N/A,5MGTABLET / ORAL-28RLD, RS1995-11-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020527-003PREMPRO0.625MG;5MGTABLET / ORAL-28RLD, RS1998-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020527-004PREMPRO0.45MG;1.5MGTABLET / ORAL-28RLD, RS2003-03-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020527-005PREMPRO0.3MG;1.5MGTABLET / ORAL-28RLD, RS2003-06-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020527-001PREMPRO0.625MG;2.5MGTABLET / ORAL-28RLD, RS1995-11-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020527-002PREMPHASE 14/140.625MG,0.625MG;N/A,5MGTABLET / ORAL-28RLD, RS1995-11-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020527-003PREMPRO0.625MG;5MGTABLET / ORAL-28RLD, RS1998-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020527-004PREMPRO0.45MG;1.5MGTABLET / ORAL-28RLD, RS2003-03-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020527-005PREMPRO0.3MG;1.5MGTABLET / ORAL-28RLD, RS2003-06-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020527-001PREMPRO0.625MG;2.5MGTABLET / ORAL-28RLD, RS1995-11-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020527-002PREMPHASE 14/140.625MG,0.625MG;N/A,5MGTABLET / ORAL-28RLD, RS1995-11-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020527-003PREMPRO0.625MG;5MGTABLET / ORAL-28RLD, RS1998-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020527-004PREMPRO0.45MG;1.5MGTABLET / ORAL-28RLD, RS2003-03-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020527-005PREMPRO0.3MG;1.5MGTABLET / ORAL-28RLD, RS2003-06-045bbf6a4d5a75…

Additional Listing Data#

Finished product
Yes
Brand name base
Prempro
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTROGENS, CONJUGATED.625 mg/1
MEDROXYPROGESTERONE ACETATE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C2QI4IOI2GInternal UNII lookup
IU5QR144QXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
150840Internal RxNorm lookup
310197Internal RxNorm lookup
1000351Internal RxNorm lookup
1000352Internal RxNorm lookup
1000355Internal RxNorm lookup
1000356Internal RxNorm lookup
1000395Internal RxNorm lookup
1000398Internal RxNorm lookup
1000486Internal RxNorm lookup
1000487Internal RxNorm lookup
1000490Internal RxNorm lookup
1000491Internal RxNorm lookup
1000496Internal RxNorm lookup
1000497Internal RxNorm lookup
1000499Internal RxNorm lookup
1000500Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fd0c0836-5d23-2183-da81-9dc7f4287052Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b8fdf1ba-dff9-e1f2-2551-c9b63aaa8dceProduct name620240606
d95be220-b30e-4165-a12d-f83825b0efb1Product name120160111
882e78d5-69f7-4a43-812f-1c1628241bbcProduct name120150910
034a0bf8-c98c-0b66-1310-f87bb3a2f8a2Product name120140508
2e1ce74f-4938-37b4-e2b4-cfd7971b45eaProduct name120140508
51a98800-9a04-9e42-2219-e588f17f9e48Product name120140508
d90784c3-64a2-2f23-9acd-d948d25bf235Product name120140508
f363ed61-d8ad-8f59-ee92-52a12578e008Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0046-1108-11Prempro28 in 1 BLISTER PACKTABLET, SUGAR COATED2839
0046-1108-11Prempro1 in 1 CARTONTABLET, SUGAR COATED139

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0046-1108-11EA - Each0046-110891cdd20f-52a1-4f60-af08-86546e804ac212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTROGENS, CONJUGATEDACTIVE INGREDIENTIU5QR144QXPREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GPREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
ESTROGENS, CONJUGATEDACTIVE MOIETYIU5QR144QXPREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESPREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2PREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WPREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
POVIDONESINACTIVE INGREDIENTFZ989GH94EPREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MPREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
SUCROSEINACTIVE INGREDIENTC151H8M554PREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28PREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0046-1108PREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) KIT PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]37Current NDC, Legacy NDC, 2 package rows20250508_fd0c0836-5d23-2183-da81-9dc7f4287052.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PremproCONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.fd0c0836-5d23-2183-da81-9dc7f42870522026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020527
application number: NDA020527
ndc (product): 0046-1108

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000487{14 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 5 MG Oral Tablet) / 14 (estrogens, conjugated (USP) 0.625 MG Oral Tablet) } Pack [Premphase 28 Day]BPCKfd0c0836-5d23-2183-da81-9dc7f428705239
1000491{28 (estrogens, conjugated (USP) 0.3 MG / medroxyprogesterone acetate 1.5 MG Oral Tablet) } Pack [Prempro 0.3/1.5 28 Day]BPCKfd0c0836-5d23-2183-da81-9dc7f428705239
1000497{28 (estrogens, conjugated (USP) 0.45 MG / medroxyprogesterone acetate 1.5 MG Oral Tablet) } Pack [Prempro 0.45/1.5 28 Day]BPCKfd0c0836-5d23-2183-da81-9dc7f428705239
1000499{28 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 2.5 MG Oral Tablet) } Pack [Prempro 0.625/2.5 28 Day]BPCKfd0c0836-5d23-2183-da81-9dc7f428705239
1000500{28 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 5 MG Oral Tablet) } Pack [Prempro 0.625/5 28 Day]BPCKfd0c0836-5d23-2183-da81-9dc7f428705239
1000486{14 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 5 MG Oral Tablet) / 14 (estrogens, conjugated (USP) 0.625 MG Oral Tablet) } PackGPCKfd0c0836-5d23-2183-da81-9dc7f428705239
1000490{28 (estrogens, conjugated (USP) 0.3 MG / medroxyprogesterone acetate 1.5 MG Oral Tablet) } PackGPCKfd0c0836-5d23-2183-da81-9dc7f428705239
1000496{28 (estrogens, conjugated (USP) 0.45 MG / medroxyprogesterone acetate 1.5 MG Oral Tablet) } PackGPCKfd0c0836-5d23-2183-da81-9dc7f428705239
1000395{28 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 2.5 MG Oral Tablet) } PackGPCKfd0c0836-5d23-2183-da81-9dc7f428705239
1000398{28 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 5 MG Oral Tablet) } PackGPCKfd0c0836-5d23-2183-da81-9dc7f428705239
1000490Estrogens Conj-Medroxyprogest Ac 0.3-1.5 MG (28) Oral Tablet 28 Day PackPSNfd0c0836-5d23-2183-da81-9dc7f428705239
1000496Estrogens Conj-Medroxyprogest Ac 0.45-1.5 MG (28) Oral Tablet 28 Day PackPSNfd0c0836-5d23-2183-da81-9dc7f428705239
1000395Estrogens Conj-Medroxyprogest Ac 0.625-2.5 MG (28) Oral Tablet 28 Day PackPSNfd0c0836-5d23-2183-da81-9dc7f428705239
1000486Estrogens Conj-Medroxyprogest Ac 0.625-5 MG (14) Oral Tablet / Estrogens Conj 0.625 MG (14) Oral Tablet 28 Day PackPSNfd0c0836-5d23-2183-da81-9dc7f428705239
1000398Estrogens Conj-Medroxyprogest Ac 0.625-5 MG (28) Oral Tablet 28 Day PackPSNfd0c0836-5d23-2183-da81-9dc7f428705239
1000351estrogens, conjugated 0.3 MG / medroxyPROGESTERone acetate 1.5 MG Oral TabletPSNfd0c0836-5d23-2183-da81-9dc7f428705239
1000352estrogens, conjugated 0.45 MG / medroxyPROGESTERone acetate 1.5 MG Oral TabletPSNfd0c0836-5d23-2183-da81-9dc7f428705239
1000355estrogens, conjugated 0.625 MG / medroxyPROGESTERone acetate 2.5 MG Oral TabletPSNfd0c0836-5d23-2183-da81-9dc7f428705239
1000356estrogens, conjugated 0.625 MG / medroxyPROGESTERone acetate 5 MG Oral TabletPSNfd0c0836-5d23-2183-da81-9dc7f428705239
310197estrogens, conjugated 0.625 MG Oral TabletPSNfd0c0836-5d23-2183-da81-9dc7f428705239
150840PREMARIN 0.625 MG Oral TabletPSNfd0c0836-5d23-2183-da81-9dc7f428705239
1000487Premphase 28 Day PackPSNfd0c0836-5d23-2183-da81-9dc7f428705239
1000491PREMPRO 0.3/1.5 28 Day PackPSNfd0c0836-5d23-2183-da81-9dc7f428705239
1000497PREMPRO 0.45/1.5 28 Day PackPSNfd0c0836-5d23-2183-da81-9dc7f428705239
1000499PREMPRO 0.625/2.5 28 Day PackPSNfd0c0836-5d23-2183-da81-9dc7f428705239
1000500PREMPRO 0.625/5 28 Day PackPSNfd0c0836-5d23-2183-da81-9dc7f428705239
150840estrogens, conjugated (USP) 0.625 MG Oral Tablet [Premarin]SBDfd0c0836-5d23-2183-da81-9dc7f428705239
1000351estrogens, conjugated (USP) 0.3 MG / medroxyprogesterone acetate 1.5 MG Oral TabletSCDfd0c0836-5d23-2183-da81-9dc7f428705239
1000352estrogens, conjugated (USP) 0.45 MG / medroxyprogesterone acetate 1.5 MG Oral TabletSCDfd0c0836-5d23-2183-da81-9dc7f428705239
1000355estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 2.5 MG Oral TabletSCDfd0c0836-5d23-2183-da81-9dc7f428705239
1000356estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 5 MG Oral TabletSCDfd0c0836-5d23-2183-da81-9dc7f428705239
310197estrogens, conjugated (USP) 0.625 MG Oral TabletSCDfd0c0836-5d23-2183-da81-9dc7f428705239
310197estrogens, conjugated (USP) 625 MCG Oral TabletSYfd0c0836-5d23-2183-da81-9dc7f428705239
150840Premarin 0.625 MG Oral TabletSYfd0c0836-5d23-2183-da81-9dc7f428705239
1000487Premphase 28 Day PackSYfd0c0836-5d23-2183-da81-9dc7f428705239
1000491Prempro 0.3/1.5 28 Day PackSYfd0c0836-5d23-2183-da81-9dc7f428705239
1000497Prempro 0.45/1.5 28 Day PackSYfd0c0836-5d23-2183-da81-9dc7f428705239
1000499Prempro 0.625/2.5 28 Day PackSYfd0c0836-5d23-2183-da81-9dc7f428705239
1000500Prempro 0.625/5 28 Day PackSYfd0c0836-5d23-2183-da81-9dc7f428705239

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0046-1108-11000461108111 BLISTER PACK in 1 CARTON (0046-1108-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK1 blister pack2012-12-030000-00-00NoNoCurrent