Home NDC 0009-3701 Caverject
Product NDC 0009-3701
11-digit product format 000093701
Labeler code 0009
Product ID 0009-3701_c9c81920-1b63-4318-9cc1-38cc4d3fa601
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alprostadil
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRACAVERNOUS
Labeler Pharmacia & Upjohn Company LLC
Application NDA020379
Marketing category NDA
Marketing start 1995-07-06
Substance ALPROSTADIL
Active strength 20.5 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 2026-12-31
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020379-001 CAVERJECT ALPROSTADIL 0.01MG/VIAL INJECTABLE / INJECTION AP RLD 1995-07-06 N020379-002 CAVERJECT ALPROSTADIL 0.02MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-07-06 N020379-003 CAVERJECT ALPROSTADIL 0.005MG/VIAL INJECTABLE / INJECTION RLD 1996-06-27 N020379-004 CAVERJECT ALPROSTADIL 0.04MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-05-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 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 N020379-001 CAVERJECT 0.01MG/VIAL INJECTABLE / INJECTION AP RLD 1995-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020379-002 CAVERJECT 0.02MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020379-003 CAVERJECT 0.005MG/VIAL INJECTABLE / INJECTION RLD 1996-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020379-004 CAVERJECT 0.04MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-05-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020379-001 CAVERJECT 0.01MG/VIAL INJECTABLE / INJECTION AP RLD 1995-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020379-002 CAVERJECT 0.02MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020379-003 CAVERJECT 0.005MG/VIAL INJECTABLE / INJECTION RLD 1996-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020379-004 CAVERJECT 0.04MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-05-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020379-001 CAVERJECT 0.01MG/VIAL INJECTABLE / INJECTION AP RLD 1995-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020379-002 CAVERJECT 0.02MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020379-003 CAVERJECT 0.005MG/VIAL INJECTABLE / INJECTION RLD 1996-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020379-004 CAVERJECT 0.04MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-05-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020379-001 CAVERJECT 0.01MG/VIAL INJECTABLE / INJECTION AP RLD 1995-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020379-002 CAVERJECT 0.02MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020379-003 CAVERJECT 0.005MG/VIAL INJECTABLE / INJECTION RLD 1996-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020379-004 CAVERJECT 0.04MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-05-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020379-001 CAVERJECT 0.01MG/VIAL INJECTABLE / INJECTION AP RLD 1995-07-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020379-002 CAVERJECT 0.02MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-07-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020379-003 CAVERJECT 0.005MG/VIAL INJECTABLE / INJECTION RLD 1996-06-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020379-004 CAVERJECT 0.04MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-05-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020379-001 CAVERJECT 0.01MG/VIAL INJECTABLE / INJECTION AP RLD 1995-07-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020379-002 CAVERJECT 0.02MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-07-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020379-003 CAVERJECT 0.005MG/VIAL INJECTABLE / INJECTION RLD 1996-06-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020379-004 CAVERJECT 0.04MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-05-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020379-001 CAVERJECT 0.01MG/VIAL INJECTABLE / INJECTION AP RLD 1995-07-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020379-002 CAVERJECT 0.02MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-07-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020379-003 CAVERJECT 0.005MG/VIAL INJECTABLE / INJECTION RLD 1996-06-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020379-004 CAVERJECT 0.04MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-05-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020379-001 CAVERJECT 0.01MG/VIAL INJECTABLE / INJECTION AP RLD 1995-07-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020379-002 CAVERJECT 0.02MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-07-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020379-003 CAVERJECT 0.005MG/VIAL INJECTABLE / INJECTION RLD 1996-06-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020379-004 CAVERJECT 0.04MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-05-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020379-001 CAVERJECT 0.01MG/VIAL INJECTABLE / INJECTION AP RLD 1995-07-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020379-002 CAVERJECT 0.02MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-07-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020379-003 CAVERJECT 0.005MG/VIAL INJECTABLE / INJECTION RLD 1996-06-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020379-004 CAVERJECT 0.04MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-05-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020379-001 CAVERJECT 0.01MG/VIAL INJECTABLE / INJECTION AP RLD 1995-07-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020379-002 CAVERJECT 0.02MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-07-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020379-003 CAVERJECT 0.005MG/VIAL INJECTABLE / INJECTION RLD 1996-06-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020379-004 CAVERJECT 0.04MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1997-05-19 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Caverject
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALPROSTADIL 20.5 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 103956 Internal RxNorm lookup 226921 Internal RxNorm lookup 226922 Internal RxNorm lookup 242691 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0009-3701-05 Caverject 6 in 1 PACKAGE INJECTION, POWDER, LYOPHILIZED, 6 19 0009-3701-08 Caverject 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALPROSTADIL ACTIVE INGREDIENT F5TD010360 CAVERJECT (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY] 6 ALPROSTADIL ACTIVE MOIETY F5TD010360 CAVERJECT (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY] 6 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH CAVERJECT (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY] 6 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB CAVERJECT (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY] 6 LACTOSE INACTIVE INGREDIENT J2B2A4N98G CAVERJECT (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY] 6 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CAVERJECT (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY] 6 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CAVERJECT (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY] 6 WATER INACTIVE INGREDIENT 059QF0KO0R CAVERJECT (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0009-3701 CAVERJECT (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMACIA & UPJOHN COMPANY LLC] 19 Current NDC, Legacy NDC, 2 package rows 20240517_a295fc1e-d82c-4f44-bc2d-a552bf594c98.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0009-3701-05 00009370105 6 VIAL, SINGLE-DOSE in 1 PACKAGE (0009-3701-05) / 1 mL in 1 VIAL, SINGLE-DOSE (0009-3701-08) 1995-07-06 0000-00-00 No No Current 0009-3701-08 00009370108 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical