FDA.reportPublic FDA data

National Council for Prescription Drug Programs indexing - billing unit

Manufacturer
National Council for Prescription Drug Programs
Effective date
2012-07-24
Label type
Indexing - Billing Unit
Version
1
Source
full-release
Hydrated at
2026-06-05 03:04:55

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0046-1105-11EA - Each0046-1105f6028d33-05ff-45a2-9ff4-feac4b6b2e7712012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0046-11050046-1105-11

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020527-001PREMPRO0.625MG;2.5MGTABLET / ORAL-28RLD, RS1995-11-1784e616aacf4f…
2026-09-14 22:38:342026-08N020527-002PREMPHASE 14/140.625MG,0.625MG;N/A,5MGTABLET / ORAL-28RLD, RS1995-11-1784e616aacf4f…
2026-09-14 22:38:342026-08N020527-003PREMPRO0.625MG;5MGTABLET / ORAL-28RLD, RS1998-01-0984e616aacf4f…
2026-09-14 22:38:342026-08N020527-004PREMPRO0.45MG;1.5MGTABLET / ORAL-28RLD, RS2003-03-1284e616aacf4f…
2026-09-14 22:38:342026-08N020527-005PREMPRO0.3MG;1.5MGTABLET / ORAL-28RLD, RS2003-06-0484e616aacf4f…
2026-08-18 06:07:402026-07N020527-001PREMPRO0.625MG;2.5MGTABLET / ORAL-28RLD, RS1995-11-17caaa826d4ba7…
2026-08-18 06:07:402026-07N020527-002PREMPHASE 14/140.625MG,0.625MG;N/A,5MGTABLET / ORAL-28RLD, RS1995-11-17caaa826d4ba7…
2026-08-18 06:07:402026-07N020527-003PREMPRO0.625MG;5MGTABLET / ORAL-28RLD, RS1998-01-09caaa826d4ba7…
2026-08-18 06:07:402026-07N020527-004PREMPRO0.45MG;1.5MGTABLET / ORAL-28RLD, RS2003-03-12caaa826d4ba7…
2026-08-18 06:07:402026-07N020527-005PREMPRO0.3MG;1.5MGTABLET / ORAL-28RLD, RS2003-06-04caaa826d4ba7…
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…

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
ndc (package): 0046-1105-11
ndc11 (package): 00046110511

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.