PROSTIN

Product NDC: 0009-3169
11-digit product format: 000093169
Labeler code: 0009
Product ID: 0009-3169_782de6bf-1523-48cc-b083-74b1b3940b81
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: alprostadil
Dosage form: INJECTION, SOLUTION
Route: INTRAVASCULAR; INTRAVENOUS
Labeler: Pharmacia & Upjohn Company LLC
Application: NDA018484
Marketing category: NDA
Marketing start: 1981-10-16
Substance: ALPROSTADIL
Active strength: 500 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018484-001	PROSTIN VR PEDIATRIC	ALPROSTADIL	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018484-001	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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018484-001	PROSTIN VR PEDIATRIC	0.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N018484-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018484-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018484-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018484-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018484-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018484-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018484-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018484-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018484-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018484-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018484-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018484-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018484-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018484-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018484-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018484-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018484-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018484-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018484-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018484-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018484-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018484-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018484-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018484-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018484-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018484-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018484-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018484-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018484-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018484-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018484-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018484-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018484-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018484-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018484-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018484-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018484-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018484-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018484-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018484-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: PROSTIN
Brand name suffix: VR PEDIATRIC
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALPROSTADIL	500 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
105467	Internal RxNorm lookup
237212	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
dea460fa-d05e-4191-8461-f185a711ad89	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	Strength	SPL version
0009-3169-01	PROSTINVR PEDIATRIC	1 mL in 1 AMPULE	INJECTION, SOLUTION	1		11
0009-3169-06	PROSTINVR PEDIATRIC	5 in 1 PACKAGE	INJECTION, SOLUTION	5		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0009-3169-01	ML - Milliliter	0009-3169	ca11b0de-38e6-4293-95d4-e959f45421e7	1	2012-07-24
0009-3169-06	ML - Milliliter	0009-3169	e4389169-e710-4dc0-a2dd-39689af27575	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALPROSTADIL	ACTIVE INGREDIENT	F5TD010360	PROSTIN VR PEDIATRIC (ALPROSTADIL) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	7
ALPROSTADIL	ACTIVE MOIETY	F5TD010360	PROSTIN VR PEDIATRIC (ALPROSTADIL) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	7
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PROSTIN VR PEDIATRIC (ALPROSTADIL) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0009-3169	PROSTIN VR PEDIATRIC (ALPROSTADIL) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY LLC]	9	Current NDC, Legacy NDC, 2 package rows	20200512_dea460fa-d05e-4191-8461-f185a711ad89.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROSTIN VR PEDIATRIC	ALPROSTADIL	Pharmacia & Upjohn Company LLC	dea460fa-d05e-4191-8461-f185a711ad89	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018484 application number: NDA018484 ndc (product): 0009-3169
PROSTIN VR PEDIATRIC	ALPROSTADIL	Pharmacia & Upjohn Company LLC	930f8c02-46a8-4cff-a484-660468ab23c3	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018484 application number: NDA018484

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
237212	alprostadil 500 MCG in 1 ML Injection	PSN	dea460fa-d05e-4191-8461-f185a711ad89	11
105467	Prostin VR Pediatric 500 MCG in 1 ML Injection	PSN	dea460fa-d05e-4191-8461-f185a711ad89	11
105467	1 ML alprostadil 0.5 MG/ML Injection [Prostin VR]	SBD	dea460fa-d05e-4191-8461-f185a711ad89	11
237212	1 ML alprostadil 0.5 MG/ML Injection	SCD	dea460fa-d05e-4191-8461-f185a711ad89	11
105467	1 ML Prostin VR 0.5 MG/ML Injection	SY	dea460fa-d05e-4191-8461-f185a711ad89	11
237212	alprostadil 500 MCG per 1 ML Injection	SY	dea460fa-d05e-4191-8461-f185a711ad89	11
105467	Prostin VR Pediatric 500 MCG per 1 ML Injection	SY	dea460fa-d05e-4191-8461-f185a711ad89	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0009-3169-01	00009316901	1 mL in 1 AMPULE	1 ml					Historical
0009-3169-06	00009316906	5 AMPULE in 1 PACKAGE (0009-3169-06) / 1 mL in 1 AMPULE (0009-3169-01)	5 ampule	1981-10-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prostin VR Pediatric ® alprostadil injection, USP	Pharmacia & Upjohn Company LLC	2026-05-19	HUMAN PRESCRIPTION DRUG LABEL	11