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 03:12:15

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52544-077-30EA - Each52544-077fbdb63dc-2351-412a-badb-a8645b8d2f5e12012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52544-07752544-077-30

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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020489-001ANDRODERMTESTOSTERONE2.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1995-09-29
N020489-002ANDRODERMTESTOSTERONE5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-05-02
N020489-003ANDRODERMTESTOSTERONE2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FILM, EXTENDED RELEASE / TRANSDERMALRLD2011-10-20
N020489-004ANDRODERMTESTOSTERONE4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FILM, EXTENDED RELEASE / TRANSDERMALRLD2011-10-20

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020489-001ANDRODERM2.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1995-09-2984e616aacf4f…
2026-09-14 22:38:342026-08N020489-002ANDRODERM5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-05-0284e616aacf4f…
2026-09-14 22:38:342026-08N020489-003ANDRODERM2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FILM, EXTENDED RELEASE / TRANSDERMALRLD2011-10-2084e616aacf4f…
2026-09-14 22:38:342026-08N020489-004ANDRODERM4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FILM, EXTENDED RELEASE / TRANSDERMALRLD2011-10-2084e616aacf4f…
2026-08-18 06:07:402026-07N020489-001ANDRODERM2.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1995-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020489-002ANDRODERM5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-05-02caaa826d4ba7…
2026-08-18 06:07:402026-07N020489-003ANDRODERM2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FILM, EXTENDED RELEASE / TRANSDERMALRLD2011-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07N020489-004ANDRODERM4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FILM, EXTENDED RELEASE / TRANSDERMALRLD2011-10-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020489-001ANDRODERM2.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1995-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020489-002ANDRODERM5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-05-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020489-003ANDRODERM2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FILM, EXTENDED RELEASE / TRANSDERMALRLD2011-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020489-004ANDRODERM4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FILM, EXTENDED RELEASE / TRANSDERMALRLD2011-10-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020489-001ANDRODERM2.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1995-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020489-002ANDRODERM5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-05-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020489-003ANDRODERM2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FILM, EXTENDED RELEASE / TRANSDERMALRLD2011-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020489-004ANDRODERM4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FILM, EXTENDED RELEASE / TRANSDERMALRLD2011-10-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N020489-001ANDRODERM2.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1995-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020489-002ANDRODERM5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-05-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020489-003ANDRODERM2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FILM, EXTENDED RELEASE / TRANSDERMALRLD2011-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020489-004ANDRODERM4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FILM, EXTENDED RELEASE / TRANSDERMALRLD2011-10-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020489-001ANDRODERM2.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1995-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020489-002ANDRODERM5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-05-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020489-003ANDRODERM2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FILM, EXTENDED RELEASE / TRANSDERMALRLD2011-10-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020489-004ANDRODERM4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FILM, EXTENDED RELEASE / TRANSDERMALRLD2011-10-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020489-001ANDRODERM2.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1995-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020489-002ANDRODERM5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-05-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020489-003ANDRODERM2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FILM, EXTENDED RELEASE / TRANSDERMALRLD2011-10-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020489-004ANDRODERM4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FILM, EXTENDED RELEASE / TRANSDERMALRLD2011-10-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020489-001ANDRODERM2.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1995-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020489-002ANDRODERM5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-05-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020489-003ANDRODERM2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FILM, EXTENDED RELEASE / TRANSDERMALRLD2011-10-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020489-004ANDRODERM4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FILM, EXTENDED RELEASE / TRANSDERMALRLD2011-10-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020489-001ANDRODERM2.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1995-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020489-002ANDRODERM5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-05-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020489-003ANDRODERM2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FILM, EXTENDED RELEASE / TRANSDERMALRLD2011-10-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020489-004ANDRODERM4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FILM, EXTENDED RELEASE / TRANSDERMALRLD2011-10-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020489-001ANDRODERM2.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1995-09-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020489-002ANDRODERM5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-05-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020489-003ANDRODERM2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FILM, EXTENDED RELEASE / TRANSDERMALRLD2011-10-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020489-004ANDRODERM4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FILM, EXTENDED RELEASE / TRANSDERMALRLD2011-10-205bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

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