Prempro

Product NDC
68258-5980
11-digit product format
682585980
Labeler code
68258
Product ID
68258-5980_cb3ae439-62fe-48c7-94de-a6e5f518a973
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
conjugated estrogens and medroxyprogesterone acetate
Dosage form
TABLET, SUGAR COATED
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
NDA020527
Marketing category
NDA
Marketing start
2009-09-21
Marketing end
0000-00-00
Substance
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
Active strength
1 mg/1; mg/1
Pharmacologic classes
Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [CS],Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68258-5980IInactivated by FDA2026-08-11
excluded packagepackage68258-598068258-5980-2IInactivated by FDA2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68258-5980-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68258-5980-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68258-5980-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68258-5980-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68258-5980-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68258-5980-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68258-5980-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68258-5980-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68258-5980-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68258-5980-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68258-5980-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68258-5980-2557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68258-5980-28af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68258-5980-2834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68258-5980-21332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68258-5980-2fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68258-5980-286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68258-5980-2bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68258-5980-28dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68258-5980-2e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68258-5980-29bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage68258-5980-2110d247fa046…a55b01930146…

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…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-5980-2Prempro28 in 1 BLISTER PACKTABLET, SUGAR COATED283
68258-5980-2Prempro1 in 1 CARTONTABLET, SUGAR COATED13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTROGENS, CONJUGATEDACTIVE INGREDIENTIU5QR144QXPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
ESTROGENS, CONJUGATEDACTIVE MOIETYIU5QR144QXPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-5980PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3Legacy NDC, 2 package rows20130314_198d547d-c985-46bc-a66f-e3182a294cb5.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000491{28 (estrogens, conjugated (USP) 0.3 MG / medroxyprogesterone acetate 1.5 MG Oral Tablet) } Pack [Prempro 0.3/1.5 28 Day]BPCK198d547d-c985-46bc-a66f-e3182a294cb53
1000499{28 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 2.5 MG Oral Tablet) } Pack [Prempro 0.625/2.5 28 Day]BPCK198d547d-c985-46bc-a66f-e3182a294cb53
1000490{28 (estrogens, conjugated (USP) 0.3 MG / medroxyprogesterone acetate 1.5 MG Oral Tablet) } PackGPCK198d547d-c985-46bc-a66f-e3182a294cb53
1000395{28 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 2.5 MG Oral Tablet) } PackGPCK198d547d-c985-46bc-a66f-e3182a294cb53
1000490Estrogens Conj-Medroxyprogest Ac 0.3-1.5 MG (28) Oral Tablet 28 Day PackPSN198d547d-c985-46bc-a66f-e3182a294cb53
1000395Estrogens Conj-Medroxyprogest Ac 0.625-2.5 MG (28) Oral Tablet 28 Day PackPSN198d547d-c985-46bc-a66f-e3182a294cb53
1000351estrogens, conjugated 0.3 MG / medroxyPROGESTERone acetate 1.5 MG Oral TabletPSN198d547d-c985-46bc-a66f-e3182a294cb53
1000355estrogens, conjugated 0.625 MG / medroxyPROGESTERone acetate 2.5 MG Oral TabletPSN198d547d-c985-46bc-a66f-e3182a294cb53
1000491PREMPRO 0.3/1.5 28 Day PackPSN198d547d-c985-46bc-a66f-e3182a294cb53
1000499PREMPRO 0.625/2.5 28 Day PackPSN198d547d-c985-46bc-a66f-e3182a294cb53
1000351estrogens, conjugated (USP) 0.3 MG / medroxyprogesterone acetate 1.5 MG Oral TabletSCD198d547d-c985-46bc-a66f-e3182a294cb53
1000355estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 2.5 MG Oral TabletSCD198d547d-c985-46bc-a66f-e3182a294cb53
1000491Prempro 0.3/1.5 28 Day PackSY198d547d-c985-46bc-a66f-e3182a294cb53
1000499Prempro 0.625/2.5 28 Day PackSY198d547d-c985-46bc-a66f-e3182a294cb53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68258-5980-26825859800228 in 1 BLISTER PACKHistorical