Caverject Impulse

Product NDC: 63539-221
Requested package NDC: 63539-221-21
11-digit product format: 635390221
Labeler code: 63539
Product ID: 63539-221_0dcd3231-552e-4243-bbc9-b8ed733d3ff4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alprostadil
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRACAVERNOUS
Labeler: U.S. Pharmaceuticals
Application: NDA021212
Marketing category: NDA
Marketing start: 2014-05-04
Marketing end: 0000-00-00
Substance: ALPROSTADIL
Active strength: 20 ug/.5mL
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: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63539-221	63539-221-21	D	Discontinued by firm		2026-08-03

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021212-001	CAVERJECT IMPULSE	ALPROSTADIL	0.01MG/VIAL	INJECTABLE / INJECTION			2002-06-11
N021212-002	CAVERJECT IMPULSE	ALPROSTADIL	0.02MG/VIAL	INJECTABLE / INJECTION			2002-06-11

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021212-001	CAVERJECT IMPULSE	0.01MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021212-002	CAVERJECT IMPULSE	0.02MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021212-001	CAVERJECT IMPULSE	0.01MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021212-002	CAVERJECT IMPULSE	0.02MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021212-001	CAVERJECT IMPULSE	0.01MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021212-002	CAVERJECT IMPULSE	0.02MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021212-001	CAVERJECT IMPULSE	0.01MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021212-002	CAVERJECT IMPULSE	0.02MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021212-001	CAVERJECT IMPULSE	0.01MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021212-002	CAVERJECT IMPULSE	0.02MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021212-001	CAVERJECT IMPULSE	0.01MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021212-002	CAVERJECT IMPULSE	0.02MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021212-001	CAVERJECT IMPULSE	0.01MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021212-002	CAVERJECT IMPULSE	0.02MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021212-001	CAVERJECT IMPULSE	0.01MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021212-002	CAVERJECT IMPULSE	0.02MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021212-001	CAVERJECT IMPULSE	0.01MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021212-002	CAVERJECT IMPULSE	0.02MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021212-001	CAVERJECT IMPULSE	0.01MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021212-002	CAVERJECT IMPULSE	0.02MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021212-001	CAVERJECT IMPULSE	0.01MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021212-002	CAVERJECT IMPULSE	0.02MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021212-001	CAVERJECT IMPULSE	0.01MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021212-002	CAVERJECT IMPULSE	0.02MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021212-001	CAVERJECT IMPULSE	0.01MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021212-002	CAVERJECT IMPULSE	0.02MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021212-001	CAVERJECT IMPULSE	0.01MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021212-002	CAVERJECT IMPULSE	0.02MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021212-001	CAVERJECT IMPULSE	0.01MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021212-002	CAVERJECT IMPULSE	0.02MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021212-001	CAVERJECT IMPULSE	0.01MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021212-002	CAVERJECT IMPULSE	0.02MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021212-001	CAVERJECT IMPULSE	0.01MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021212-002	CAVERJECT IMPULSE	0.02MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021212-001	CAVERJECT IMPULSE	0.01MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021212-002	CAVERJECT IMPULSE	0.02MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021212-001	CAVERJECT IMPULSE	0.01MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021212-002	CAVERJECT IMPULSE	0.02MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021212-001	CAVERJECT IMPULSE	0.01MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021212-002	CAVERJECT IMPULSE	0.02MG/VIAL	INJECTABLE / INJECTION	2002-06-11	`782e0a99824c…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALPROSTADIL	ACTIVE INGREDIENT	F5TD010360	CAVERJECT IMPULSE (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [U.S. PHARMACEUTICALS]	1
ALPROSTADIL	ACTIVE MOIETY	F5TD010360	CAVERJECT IMPULSE (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [U.S. PHARMACEUTICALS]	1
ALFADEX	INACTIVE INGREDIENT	Z1LH97KTRM	CAVERJECT IMPULSE (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [U.S. PHARMACEUTICALS]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	CAVERJECT IMPULSE (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [U.S. PHARMACEUTICALS]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	CAVERJECT IMPULSE (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [U.S. PHARMACEUTICALS]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	CAVERJECT IMPULSE (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [U.S. PHARMACEUTICALS]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	CAVERJECT IMPULSE (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [U.S. PHARMACEUTICALS]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CAVERJECT IMPULSE (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [U.S. PHARMACEUTICALS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CAVERJECT IMPULSE (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [U.S. PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63539-221	CAVERJECT IMPULSE (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [U.S. PHARMACEUTICALS]	3	Legacy NDC	20240903_d8f85a7e-becb-4e15-9829-40e8f359140a.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
Caverject Impulse	ALPROSTADIL	Pharmacia & Upjohn Company LLC	4dec1dbd-c63b-4a1b-81cb-c8d29696cc40	2024-02-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021212 application number: NDA021212

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63539-221-21	63539022121	2 SYRINGE in 1 CARTON (63539-221-21) > .5 mL in 1 SYRINGE (63539-221-20)	2 syringe	2014-05-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Caverject Impulse	U.S. Pharmaceuticals \| Pfizer Manufacturing Belgium NV \| Pharmacia & Upjohn Company LLC	2024-07-23	HUMAN PRESCRIPTION DRUG LABEL	3