Edex

Product NDC: 52244-040
11-digit product format: 522440040
Labeler code: 52244
Product ID: 52244-040_66cf008c-1361-4fd1-8e5c-3e95981f8a76
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: alprostadil
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRACAVERNOUS
Labeler: Endo USA, Inc.
Application: NDA020649
Marketing category: NDA
Marketing start: 2012-03-15
Substance: ALPROSTADIL
Active strength: 40 ug/mL
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: 2027-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020649-001	EDEX	ALPROSTADIL	0.005MG/VIAL	INJECTABLE / INJECTION			1997-06-12
N020649-002	EDEX	ALPROSTADIL	0.01MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12
N020649-003	EDEX	ALPROSTADIL	0.02MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12
N020649-004	EDEX	ALPROSTADIL	0.04MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-06-12
N020649-005	EDEX	ALPROSTADIL	0.01MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30
N020649-006	EDEX	ALPROSTADIL	0.02MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30
N020649-007	EDEX	ALPROSTADIL	0.04MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N020649-002	AP
N020649-003	AP
N020649-004	AP

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 8 · 287 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020649-001	EDEX	0.005MG/VIAL	INJECTABLE / INJECTION			1997-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020649-002	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020649-003	EDEX	0.02MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020649-004	EDEX	0.04MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020649-005	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020649-006	EDEX	0.02MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020649-007	EDEX	0.04MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020649-001	EDEX	0.005MG/VIAL	INJECTABLE / INJECTION			1997-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020649-002	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020649-003	EDEX	0.02MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020649-004	EDEX	0.04MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020649-005	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020649-006	EDEX	0.02MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020649-007	EDEX	0.04MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020649-001	EDEX	0.005MG/VIAL	INJECTABLE / INJECTION			1997-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020649-002	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020649-003	EDEX	0.02MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020649-004	EDEX	0.04MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020649-005	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020649-006	EDEX	0.02MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020649-007	EDEX	0.04MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020649-001	EDEX	0.005MG/VIAL	INJECTABLE / INJECTION			1997-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020649-002	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020649-003	EDEX	0.02MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020649-004	EDEX	0.04MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020649-005	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020649-006	EDEX	0.02MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020649-007	EDEX	0.04MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020649-001	EDEX	0.005MG/VIAL	INJECTABLE / INJECTION			1997-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020649-002	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020649-003	EDEX	0.02MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020649-004	EDEX	0.04MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020649-005	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020649-006	EDEX	0.02MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020649-007	EDEX	0.04MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020649-001	EDEX	0.005MG/VIAL	INJECTABLE / INJECTION			1997-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020649-002	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020649-003	EDEX	0.02MG/VIAL	INJECTABLE / INJECTION	AP	RLD	1997-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020649-004	EDEX	0.04MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020649-005	EDEX	0.01MG/VIAL	INJECTABLE / INJECTION		RLD, RS	1998-07-30	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020649-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020649-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020649-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020649-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020649-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020649-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020649-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020649-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020649-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020649-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020649-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020649-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020649-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020649-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020649-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020649-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020649-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020649-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020649-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020649-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020649-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020649-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020649-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020649-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020649-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020649-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020649-004	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020649-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020649-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020649-004	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020649-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020649-003	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020649-004	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020649-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020649-003	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020649-004	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020649-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020649-003	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020649-004	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020649-002	AP	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Edex
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALPROSTADIL	40 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F5TD010360	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1234236	Internal RxNorm lookup
1234238	Internal RxNorm lookup
1234239	Internal RxNorm lookup
1234240	Internal RxNorm lookup
1234241	Internal RxNorm lookup
1234242	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e8b8ec8d-1318-43e4-a182-446e9f9579de	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4a3c3468-d7dd-dbc7-68a7-e177b6ff0c9c	Product name	1	20140508
9a159c5b-579d-e616-cae2-48cf73594159	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52244-040-01	Edex	1 mL in 1 CARTRIDGE	INJECTION, POWDER, LYOPHILIZED,	1	16
52244-040-02	Edex	2 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	2	16
52244-040-02	Edex	1 in 1 BLISTER PACK	INJECTION, POWDER, LYOPHILIZED,	1	16
52244-040-06	Edex	6 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	6	16
52244-040-06	Edex	1 in 1 BLISTER PACK	INJECTION, POWDER, LYOPHILIZED,	1	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52244-040-02	EA - Each	52244-040	18882348-6992-4ad5-890c-7bac309f72a8	1	2012-07-24
52244-040-06	EA - Each	52244-040	e6aa1ffd-cbaf-4e2c-a0f3-190671784d5a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALPROSTADIL	ACTIVE INGREDIENT	F5TD010360	EDEX (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTIENT PHARMACEUTICALS, LLC]	2
ALPROSTADIL	ACTIVE MOIETY	F5TD010360	EDEX (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTIENT PHARMACEUTICALS, LLC]	2
ALFADEX	INACTIVE INGREDIENT	Z1LH97KTRM	EDEX (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTIENT PHARMACEUTICALS, LLC]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	EDEX (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTIENT PHARMACEUTICALS, LLC]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	EDEX (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTIENT PHARMACEUTICALS, LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	EDEX (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTIENT PHARMACEUTICALS, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52244-040	EDEX (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.]	14	Current NDC, Legacy NDC, 5 package rows	20240425_e8b8ec8d-1318-43e4-a182-446e9f9579de.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Edex	ALPROSTADIL	Endo USA, Inc.	e8b8ec8d-1318-43e4-a182-446e9f9579de	2024-03-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020649 application number: NDA020649 ndc (product): 52244-040

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5TD010360	ALPROSTADIL	745-65-3	ALPROSTADIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1234236	alprostadil 10 MCG in 1 ML Cartridge	PSN	e8b8ec8d-1318-43e4-a182-446e9f9579de	16
1234239	alprostadil 20 MCG in 1 ML Cartridge	PSN	e8b8ec8d-1318-43e4-a182-446e9f9579de	16
1234241	alprostadil 40 MCG in 1 ML Cartridge	PSN	e8b8ec8d-1318-43e4-a182-446e9f9579de	16
1234238	edex 10 MCG in 1 ML Cartridge	PSN	e8b8ec8d-1318-43e4-a182-446e9f9579de	16
1234240	edex 20 MCG in 1 ML Cartridge	PSN	e8b8ec8d-1318-43e4-a182-446e9f9579de	16
1234242	edex 40 MCG in 1 ML Cartridge	PSN	e8b8ec8d-1318-43e4-a182-446e9f9579de	16
1234238	1 ML alprostadil 0.01 MG/ML Cartridge [Edex]	SBD	e8b8ec8d-1318-43e4-a182-446e9f9579de	16
1234240	1 ML alprostadil 0.02 MG/ML Cartridge [Edex]	SBD	e8b8ec8d-1318-43e4-a182-446e9f9579de	16
1234242	1 ML alprostadil 0.04 MG/ML Cartridge [Edex]	SBD	e8b8ec8d-1318-43e4-a182-446e9f9579de	16
1234236	1 ML alprostadil 0.01 MG/ML Cartridge	SCD	e8b8ec8d-1318-43e4-a182-446e9f9579de	16
1234239	1 ML alprostadil 0.02 MG/ML Cartridge	SCD	e8b8ec8d-1318-43e4-a182-446e9f9579de	16
1234241	1 ML alprostadil 0.04 MG/ML Cartridge	SCD	e8b8ec8d-1318-43e4-a182-446e9f9579de	16
1234238	1 ML Edex 0.01 MG/ML Cartridge	SY	e8b8ec8d-1318-43e4-a182-446e9f9579de	16
1234240	1 ML Edex 0.02 MG/ML Cartridge	SY	e8b8ec8d-1318-43e4-a182-446e9f9579de	16
1234242	1 ML Edex 0.04 MG/ML Cartridge	SY	e8b8ec8d-1318-43e4-a182-446e9f9579de	16
1234236	alprostadil 10 MCG per 1 ML Cartridge	SY	e8b8ec8d-1318-43e4-a182-446e9f9579de	16
1234239	alprostadil 20 MCG per 1 ML Cartridge	SY	e8b8ec8d-1318-43e4-a182-446e9f9579de	16
1234241	alprostadil 40 MCG per 1 ML Cartridge	SY	e8b8ec8d-1318-43e4-a182-446e9f9579de	16
1234238	Edex 10 MCG per 1 ML Cartridge	SY	e8b8ec8d-1318-43e4-a182-446e9f9579de	16
1234240	Edex 20 MCG per 1 ML Cartridge	SY	e8b8ec8d-1318-43e4-a182-446e9f9579de	16
1234242	Edex 40 MCG per 1 ML Cartridge	SY	e8b8ec8d-1318-43e4-a182-446e9f9579de	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52244-040-01	52244004001	1 mL in 1 CARTRIDGE	1 ml					Historical
52244-040-02	52244004002	2 BLISTER PACK in 1 CARTON (52244-040-02) / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE (52244-040-01)	2 blister pack	2012-03-15	0000-00-00	No	No	Current
52244-040-06	52244004006	6 BLISTER PACK in 1 CARTON (52244-040-06) / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE (52244-040-01)	6 blister pack	2012-03-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
edex ® (alprostadil for injection)	Endo USA, Inc.	2024-03-27	HUMAN PRESCRIPTION DRUG LABEL	17
Lannett Company, Inc. \| SGS Life Science Services \| Eurofins Lancaster Laboratories, Inc \| NEOLPHARMA, INC. \| Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) \| Siegfried PharmaChemikalien Minden Gmbh \| Aesica Pharmaceuticals GmbH \| Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse) \| Aspen Oss B.V. \| Mipharm SPA blanket no changes certification of product listing	Lannett Company, Inc. \| SGS Life Science Services \| Eurofins Lancaster Laboratories, Inc \| NEOLPHARMA, INC. \| Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) \| Siegfried PharmaChemikalien Minden Gmbh \| Aesica Pharmaceuticals GmbH \| Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse) \| Aspen Oss B.V. \| Mipharm SPA	2017-10-11	BLANKET NO CHANGES CERTIFICATION OF PRODUCT LISTING	1