Curosurf

Product NDC: 10122-510
11-digit product format: 101220510
Labeler code: 10122
Product ID: 10122-510_6b713a41-2648-43f4-9a10-cc41a7e83ca0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: poractant alfa
Dosage form: SUSPENSION
Route: ENDOTRACHEAL
Labeler: Chiesi USA, Inc.
Application: BLA020744
Marketing category: BLA
Marketing start: 1999-11-18
Substance: PORACTANT ALFA
Active strength: 80 mg/mL
Pharmacologic classes: Alveolar Surface Tension Reduction [PE], Surfactant Activity [MoA], Surfactant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
PORACTANT ALFA	80 mg/mL

Field, Values table
Field	Values
Unii	KE3U2023NP
Rxcui	259216, 261329

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
93740178-6909-93a5-3691-f32fb4cdf0c5	Product name	2	20200325
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10122-510-01	Curosurf	1.5 mL in 1 VIAL, GLASS	SUSPENSION	1.5		45
10122-510-03	Curosurf	3.0 mL in 1 VIAL, GLASS	SUSPENSION	3.0		45

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10122-510-01	ML - Milliliter	10122-510	e02283a7-0b59-4cd2-a819-5f0fac173346	1	2012-07-24
10122-510-03	ML - Milliliter	10122-510	a5ba4409-41be-43a2-92d5-410bc0cd6a6c	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PORACTANT ALFA	ACTIVE INGREDIENT	KE3U2023NP	CUROSURF (PORACTANT ALFA) SUSPENSION [CHIESI USA, INC.]	34
PORACTANT ALFA	ACTIVE MOIETY	KE3U2023NP	CUROSURF (PORACTANT ALFA) SUSPENSION [CHIESI USA, INC.]	34
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	CUROSURF (PORACTANT ALFA) SUSPENSION [CHIESI USA, INC.]	34
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CUROSURF (PORACTANT ALFA) SUSPENSION [CHIESI USA, INC.]	34

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10122-510	CUROSURF (PORACTANT ALFA) SUSPENSION [CHIESI USA, INC.]	44	Current NDC, Legacy NDC, 2 package rows	20220505_99bef307-00bd-4379-9f45-ede1380e74d4.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KE3U2023NP	PORACTANT ALFA	129069-19-8	PORACTANT ALFA

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
261329	CUROSURF 80 MG/ML Intratracheal Suspension	PSN	99bef307-00bd-4379-9f45-ede1380e74d4	45
259216	poractant alfa 80 MG/ML Intratracheal Suspension	PSN	99bef307-00bd-4379-9f45-ede1380e74d4	45
261329	poractant alfa 80 MG/ML Intratracheal Suspension [Curosurf]	SBD	99bef307-00bd-4379-9f45-ede1380e74d4	45
259216	poractant alfa 80 MG/ML Intratracheal Suspension	SCD	99bef307-00bd-4379-9f45-ede1380e74d4	45
261329	Curosurf 80 MG/ML Intratracheal Suspension	SY	99bef307-00bd-4379-9f45-ede1380e74d4	45

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10122-510-01	10122051001	1.5 mL in 1 VIAL, GLASS (10122-510-01)	1.5 ml	1999-11-18	0000-00-00	No	No	Current
10122-510-03	10122051003	3 mL in 1 VIAL, GLASS (10122-510-03)	3 ml	1999-11-18	0000-00-00	No	No	Current