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#

Finished product: Yes
Brand name base: Curosurf
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
KE3U2023NP	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
259216	Internal RxNorm lookup
261329	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
99bef307-00bd-4379-9f45-ede1380e74d4	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

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

DailyMed Billing Units#

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

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

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

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
Curosurf	PORACTANT ALFA	Chiesi USA, Inc.	99bef307-00bd-4379-9f45-ede1380e74d4	2025-12-10	Warnings, Adverse reactions	Exact identifier application number: BLA020744 ndc (product): 10122-510

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
020744	Curosurf	poractant alfa	351(a)	Rx	2026-08-01

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

DailyMed RxNorm Mappings#

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

Packages#

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