MUSE

Product NDC
0037-8130
11-digit product format
000378130
Labeler code
0037
Product ID
0037-8130_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
0000-00-00
Substance
ALPROSTADIL
Active strength
500 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
2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0037-8130DDiscontinued by firm2026-08-03
excluded packagepackage0037-81300037-8130-06DDiscontinued by firm2026-08-03
excluded packagepackage0037-81300037-8130-56DDiscontinued 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 · 36 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 packagepackage0037-8130-56d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0037-8130-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0037-8130-56f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0037-8130-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0037-8130-562ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0037-8130-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0037-8130-56a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0037-8130-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0037-8130-56cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0037-8130-06cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0037-8130-56cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0037-8130-06cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0037-8130-56302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0037-8130-06302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0037-8130-56ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0037-8130-06ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0037-8130-560efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0037-8130-060efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0037-8130-56ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0037-8130-06ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0037-8130-56367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0037-8130-06367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0037-8130-56557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0037-8130-06557ba5c1ecfa…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…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0037-8130-062024-01-30C16284748780-11030e365-29df-111a-e063-dadaa90a10e2MUSE ® (alprostadil) urethral suppository
0037-8130-562024-01-30C16284748780-11030e365-29df-111a-e063-dadaa90a10e2MUSE ® (alprostadil) urethral suppository

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0037-8130-01EA - Each0037-81307c362625-9a32-4a43-8edd-054869be679c12012-07-24
0037-8130-06EA - Each0037-81307f129ff3-0a89-43b9-a4ee-f481996efbf512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AlprostadilACTIVE INGREDIENTF5TD010360MUSE (ALPROSTADIL) SUPPOSITORY [MEDA PHARMACEUTICALS INC.]10
AlprostadilACTIVE MOIETYF5TD010360MUSE (ALPROSTADIL) SUPPOSITORY [MEDA PHARMACEUTICALS INC.]10
Polyethylene Glycol 1450INACTIVE INGREDIENTOJ4Z5Z32L4MUSE (ALPROSTADIL) SUPPOSITORY [MEDA PHARMACEUTICALS INC.]10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0037-8130-06000378130066 POUCH in 1 CARTON (0037-8130-06) > 1 SUPPOSITORY in 1 POUCH (0037-8130-01) 6 pouch2011-07-220000-00-00NoNoCurrent
0037-8130-56000378130566 POUCH in 1 CARTON (0037-8130-56) > 1 SUPPOSITORY in 1 POUCH (0037-8130-01) 6 pouch2011-07-220000-00-00YesNoCurrent