MUSE

Product NDC
0037-8110
Requested package NDC
0037-8110-56
11-digit product format
000378110
Labeler code
0037
Product ID
0037-8110_0209b68d-e74a-43a9-ad21-c9bca0293f0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprostadil
Dosage form
SUPPOSITORY
Route
URETHRAL
Labeler
Meda Pharmaceuticals Inc.
Application
NDA020700
Marketing category
NDA
Marketing start
2011-07-22
Marketing end
2022-04-30
Substance
ALPROSTADIL
Active strength
125 ug/1
Pharmacologic classes
Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0037-81100037-8110-56DDiscontinued by firm2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020700-001MUSEALPROSTADIL0.125MGSUPPOSITORY / URETHRALRLD1996-11-19
N020700-002MUSEALPROSTADIL0.25MGSUPPOSITORY / URETHRALRLD1996-11-19
N020700-003MUSEALPROSTADIL0.5MGSUPPOSITORY / URETHRALRLD1996-11-19
N020700-004MUSEALPROSTADIL1MGSUPPOSITORY / URETHRALRLD1996-11-19

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020700-001MUSE0.125MGSUPPOSITORY / URETHRALRLD1996-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020700-002MUSE0.25MGSUPPOSITORY / URETHRALRLD1996-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020700-003MUSE0.5MGSUPPOSITORY / URETHRALRLD1996-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020700-004MUSE1MGSUPPOSITORY / URETHRALRLD1996-11-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020700-001MUSE0.125MGSUPPOSITORY / URETHRALRLD1996-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020700-002MUSE0.25MGSUPPOSITORY / URETHRALRLD1996-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020700-003MUSE0.5MGSUPPOSITORY / URETHRALRLD1996-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020700-004MUSE1MGSUPPOSITORY / URETHRALRLD1996-11-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020700-001MUSE0.125MGSUPPOSITORY / URETHRALRLD1996-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020700-002MUSE0.25MGSUPPOSITORY / URETHRALRLD1996-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020700-003MUSE0.5MGSUPPOSITORY / URETHRALRLD1996-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020700-004MUSE1MGSUPPOSITORY / URETHRALRLD1996-11-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020700-001MUSE0.125MGSUPPOSITORY / URETHRALRLD1996-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020700-002MUSE0.25MGSUPPOSITORY / URETHRALRLD1996-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020700-003MUSE0.5MGSUPPOSITORY / URETHRALRLD1996-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020700-004MUSE1MGSUPPOSITORY / URETHRALRLD1996-11-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020700-001MUSE0.125MGSUPPOSITORY / URETHRALRLD1996-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020700-002MUSE0.25MGSUPPOSITORY / URETHRALRLD1996-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020700-003MUSE0.5MGSUPPOSITORY / URETHRALRLD1996-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020700-004MUSE1MGSUPPOSITORY / URETHRALRLD1996-11-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020700-001MUSE0.125MGSUPPOSITORY / URETHRALRLD1996-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020700-002MUSE0.25MGSUPPOSITORY / URETHRALRLD1996-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020700-003MUSE0.5MGSUPPOSITORY / URETHRALRLD1996-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020700-004MUSE1MGSUPPOSITORY / URETHRALRLD1996-11-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020700-001MUSE0.125MGSUPPOSITORY / URETHRALRLD1996-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020700-002MUSE0.25MGSUPPOSITORY / URETHRALRLD1996-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020700-003MUSE0.5MGSUPPOSITORY / URETHRALRLD1996-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020700-004MUSE1MGSUPPOSITORY / URETHRALRLD1996-11-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020700-001MUSE0.125MGSUPPOSITORY / URETHRALRLD1996-11-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020700-002MUSE0.25MGSUPPOSITORY / URETHRALRLD1996-11-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020700-003MUSE0.5MGSUPPOSITORY / URETHRALRLD1996-11-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020700-004MUSE1MGSUPPOSITORY / URETHRALRLD1996-11-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020700-001MUSE0.125MGSUPPOSITORY / URETHRALRLD1996-11-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020700-002MUSE0.25MGSUPPOSITORY / URETHRALRLD1996-11-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020700-003MUSE0.5MGSUPPOSITORY / URETHRALRLD1996-11-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020700-004MUSE1MGSUPPOSITORY / URETHRALRLD1996-11-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020700-001MUSE0.125MGSUPPOSITORY / URETHRALRLD1996-11-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N020700-002MUSE0.25MGSUPPOSITORY / URETHRALRLD1996-11-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N020700-003MUSE0.5MGSUPPOSITORY / URETHRALRLD1996-11-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N020700-004MUSE1MGSUPPOSITORY / URETHRALRLD1996-11-19d06236e962d9…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0037-8110-01EA - Each0037-8110fdc00518-7801-4b4e-bb7b-9963abb24b0d12012-07-24
0037-8110-06EA - Each0037-81103c0a4e50-8db3-49db-83c8-3e991eccbfb812012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0037-8110-56000378110566 POUCH in 1 CARTON (0037-8110-56) > 1 SUPPOSITORY in 1 POUCH (0037-8110-01) 6 pouch2011-07-222022-04-30YesNoCurrent