Caverject Impulse

Product NDC
0009-5181
11-digit product format
000095181
Labeler code
0009
Product ID
0009-5181_eeb7c131-8178-44e1-b266-6306dc162a9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprostadil
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRACAVERNOUS
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA021212
Marketing category
NDA
Marketing start
2002-06-11
Substance
ALPROSTADIL
Active strength
10 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
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021212-001CAVERJECT IMPULSEALPROSTADIL0.01MG/VIALINJECTABLE / INJECTION2002-06-11
N021212-002CAVERJECT IMPULSEALPROSTADIL0.02MG/VIALINJECTABLE / INJECTION2002-06-11

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021212-001CAVERJECT IMPULSE0.01MG/VIALINJECTABLE / INJECTION2002-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021212-002CAVERJECT IMPULSE0.02MG/VIALINJECTABLE / INJECTION2002-06-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021212-001CAVERJECT IMPULSE0.01MG/VIALINJECTABLE / INJECTION2002-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021212-002CAVERJECT IMPULSE0.02MG/VIALINJECTABLE / INJECTION2002-06-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021212-001CAVERJECT IMPULSE0.01MG/VIALINJECTABLE / INJECTION2002-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021212-002CAVERJECT IMPULSE0.02MG/VIALINJECTABLE / INJECTION2002-06-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021212-001CAVERJECT IMPULSE0.01MG/VIALINJECTABLE / INJECTION2002-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021212-002CAVERJECT IMPULSE0.02MG/VIALINJECTABLE / INJECTION2002-06-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021212-001CAVERJECT IMPULSE0.01MG/VIALINJECTABLE / INJECTION2002-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021212-002CAVERJECT IMPULSE0.02MG/VIALINJECTABLE / INJECTION2002-06-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021212-001CAVERJECT IMPULSE0.01MG/VIALINJECTABLE / INJECTION2002-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021212-002CAVERJECT IMPULSE0.02MG/VIALINJECTABLE / INJECTION2002-06-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021212-001CAVERJECT IMPULSE0.01MG/VIALINJECTABLE / INJECTION2002-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021212-002CAVERJECT IMPULSE0.02MG/VIALINJECTABLE / INJECTION2002-06-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021212-001CAVERJECT IMPULSE0.01MG/VIALINJECTABLE / INJECTION2002-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021212-002CAVERJECT IMPULSE0.02MG/VIALINJECTABLE / INJECTION2002-06-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021212-001CAVERJECT IMPULSE0.01MG/VIALINJECTABLE / INJECTION2002-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021212-002CAVERJECT IMPULSE0.02MG/VIALINJECTABLE / INJECTION2002-06-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021212-001CAVERJECT IMPULSE0.01MG/VIALINJECTABLE / INJECTION2002-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10N021212-002CAVERJECT IMPULSE0.02MG/VIALINJECTABLE / INJECTION2002-06-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021212-001CAVERJECT IMPULSE0.01MG/VIALINJECTABLE / INJECTION2002-06-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021212-002CAVERJECT IMPULSE0.02MG/VIALINJECTABLE / INJECTION2002-06-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021212-001CAVERJECT IMPULSE0.01MG/VIALINJECTABLE / INJECTION2002-06-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021212-002CAVERJECT IMPULSE0.02MG/VIALINJECTABLE / INJECTION2002-06-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021212-001CAVERJECT IMPULSE0.01MG/VIALINJECTABLE / INJECTION2002-06-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021212-002CAVERJECT IMPULSE0.02MG/VIALINJECTABLE / INJECTION2002-06-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021212-001CAVERJECT IMPULSE0.01MG/VIALINJECTABLE / INJECTION2002-06-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021212-002CAVERJECT IMPULSE0.02MG/VIALINJECTABLE / INJECTION2002-06-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021212-001CAVERJECT IMPULSE0.01MG/VIALINJECTABLE / INJECTION2002-06-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021212-002CAVERJECT IMPULSE0.02MG/VIALINJECTABLE / INJECTION2002-06-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021212-001CAVERJECT IMPULSE0.01MG/VIALINJECTABLE / INJECTION2002-06-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021212-002CAVERJECT IMPULSE0.02MG/VIALINJECTABLE / INJECTION2002-06-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021212-001CAVERJECT IMPULSE0.01MG/VIALINJECTABLE / INJECTION2002-06-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021212-002CAVERJECT IMPULSE0.02MG/VIALINJECTABLE / INJECTION2002-06-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021212-001CAVERJECT IMPULSE0.01MG/VIALINJECTABLE / INJECTION2002-06-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021212-002CAVERJECT IMPULSE0.02MG/VIALINJECTABLE / INJECTION2002-06-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021212-001CAVERJECT IMPULSE0.01MG/VIALINJECTABLE / INJECTION2002-06-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021212-002CAVERJECT IMPULSE0.02MG/VIALINJECTABLE / INJECTION2002-06-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021212-001CAVERJECT IMPULSE0.01MG/VIALINJECTABLE / INJECTION2002-06-11782e0a99824c…
2021-12-28 21:50 UTC2021-12N021212-002CAVERJECT IMPULSE0.02MG/VIALINJECTABLE / INJECTION2002-06-11782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Caverject Impulse
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPROSTADIL10 ug/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5TD010360Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
763470Internal RxNorm lookup
763472Internal RxNorm lookup
763473Internal RxNorm lookup
763474Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4dec1dbd-c63b-4a1b-81cb-c8d29696cc40Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4a3c3468-d7dd-dbc7-68a7-e177b6ff0c9cProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
9a159c5b-579d-e616-cae2-48cf73594159Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0009-5181-01Caverject Impulse2 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,216
0009-5181-10Caverject Impulse0.5 mL in 1 SYRINGEINJECTION, POWDER, LYOPHILIZED,0.516

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-5181-01EA - Each0009-518106d82417-bb35-46d5-88f6-0a3f17f1d70412012-07-24
0009-5181-10EA - Each0009-5181567debb0-8474-42b7-9c47-3329bdcbf72212019-09-05

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-5181CAVERJECT IMPULSE (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]16Current NDC, Legacy NDC, 2 package rows20240302_4dec1dbd-c63b-4a1b-81cb-c8d29696cc40.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Caverject ImpulseALPROSTADILPharmacia & Upjohn Company LLC4dec1dbd-c63b-4a1b-81cb-c8d29696cc402024-02-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 021212
application number: NDA021212
ndc (product): 0009-5181

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
763470alprostadil 10 MCG in 0.5 ML Prefilled SyringePSN4dec1dbd-c63b-4a1b-81cb-c8d29696cc4016
763473alprostadil 20 MCG in 0.5 ML Prefilled SyringePSN4dec1dbd-c63b-4a1b-81cb-c8d29696cc4016
763472Caverject Impulse 10 MCG in 0.5 ML Prefilled SyringePSN4dec1dbd-c63b-4a1b-81cb-c8d29696cc4016
763474Caverject Impulse 20 MCG in 0.5 ML Prefilled SyringePSN4dec1dbd-c63b-4a1b-81cb-c8d29696cc4016
7634720.5 ML alprostadil 0.02 MG/ML Prefilled Syringe [Caverject]SBD4dec1dbd-c63b-4a1b-81cb-c8d29696cc4016
7634740.5 ML alprostadil 0.04 MG/ML Prefilled Syringe [Caverject]SBD4dec1dbd-c63b-4a1b-81cb-c8d29696cc4016
7634700.5 ML alprostadil 0.02 MG/ML Prefilled SyringeSCD4dec1dbd-c63b-4a1b-81cb-c8d29696cc4016
7634730.5 ML alprostadil 0.04 MG/ML Prefilled SyringeSCD4dec1dbd-c63b-4a1b-81cb-c8d29696cc4016
7634720.5 ML Caverject 0.02 MG/ML Prefilled SyringeSY4dec1dbd-c63b-4a1b-81cb-c8d29696cc4016
7634740.5 ML Caverject 0.04 MG/ML Prefilled SyringeSY4dec1dbd-c63b-4a1b-81cb-c8d29696cc4016
763470alprostadil 0.01 MG per 0.5 ML Prefilled SyringeSY4dec1dbd-c63b-4a1b-81cb-c8d29696cc4016
763473alprostadil 0.02 MG per 0.5 ML Prefilled SyringeSY4dec1dbd-c63b-4a1b-81cb-c8d29696cc4016
763470alprostadil 10 MCG per 0.5 ML Prefilled SyringeSY4dec1dbd-c63b-4a1b-81cb-c8d29696cc4016
763473alprostadil 20 MCG per 0.5 ML Prefilled SyringeSY4dec1dbd-c63b-4a1b-81cb-c8d29696cc4016
763474Caverject 0.02 MG per 0.5 ML Prefilled SyringeSY4dec1dbd-c63b-4a1b-81cb-c8d29696cc4016
763472Caverject 10 MCG per 0.5 ML Prefilled SyringeSY4dec1dbd-c63b-4a1b-81cb-c8d29696cc4016
763472Caverject Impulse 0.01 MG per 0.5 ML Prefilled SyringeSY4dec1dbd-c63b-4a1b-81cb-c8d29696cc4016
763474Caverject Impulse 20 MCG per 0.5 ML Prefilled SyringeSY4dec1dbd-c63b-4a1b-81cb-c8d29696cc4016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-5181-01000095181012 SYRINGE in 1 CARTON (0009-5181-01) / .5 mL in 1 SYRINGE (0009-5181-10) 2 syringe2002-06-110000-00-00NoNoCurrent
0009-5181-10000095181100.5 mL in 1 SYRINGE0.5 mlHistorical