American Cockroach

Product NDC: 49288-0148
11-digit product format: 492880148
Labeler code: 49288
Product ID: 49288-0148_0c2a583c-28b8-4184-9f4d-9feba1e683c9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: American Cockroach
Dosage form: INJECTION, SOLUTION
Route: INTRADERMAL; SUBCUTANEOUS
Labeler: Antigen Laboratories, Inc.
Application: BLA102223
Marketing category: BLA
Marketing start: 1992-04-13
Marketing end: 0000-00-00
Substance: PERIPLANETA AMERICANA
Active strength: 0 g/mL
Pharmacologic classes: Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [CS],Allergens [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49288-0148-1	2019-10-21	C162847	48780-1	956f9ecf-c8f7-621f-e053-dbdaa90a74ad	Allergenic Extract
49288-0148-2	2019-10-21	C162847	48780-1	956f9ecf-c8f7-621f-e053-dbdaa90a74ad	Allergenic Extract
49288-0148-3	2019-10-21	C162847	48780-1	956f9ecf-c8f7-621f-e053-dbdaa90a74ad	Allergenic Extract
49288-0148-4	2019-10-21	C162847	48780-1	956f9ecf-c8f7-621f-e053-dbdaa90a74ad	Allergenic Extract
49288-0148-5	2019-10-21	C162847	48780-1	956f9ecf-c8f7-621f-e053-dbdaa90a74ad	Allergenic Extract

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49288-0148-1	American Cockroach	2 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	2	2
49288-0148-2	American Cockroach	5 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	5	2
49288-0148-3	American Cockroach	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10	2
49288-0148-4	American Cockroach	30 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	30	2
49288-0148-5	American Cockroach	50 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	50	2

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PERIPLANETA AMERICANA	ACTIVE INGREDIENT	2RQ1L9N089	AMERICAN COCKROACH INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	2
PERIPLANETA AMERICANA	ACTIVE MOIETY	2RQ1L9N089	AMERICAN COCKROACH INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	AMERICAN COCKROACH INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	2
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	AMERICAN COCKROACH INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	AMERICAN COCKROACH INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	AMERICAN COCKROACH INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49288-0148	AMERICAN COCKROACH INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	2	Legacy NDC, 5 package rows	20091119_ef112633-e979-4933-b34b-e4d5756a90dc.zip

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
2RQ1L9N089	PERIPLANETA AMERICANA	PERIPLANETA AMERICANA

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
966777	American cockroach allergenic extract 100 MG/ML Injectable Solution	PSN	ef112633-e979-4933-b34b-e4d5756a90dc	2
966709	American cockroach allergenic extract 20 MG/mL Injectable Solution	PSN	ef112633-e979-4933-b34b-e4d5756a90dc	2
905261	American cockroach allergenic extract 50 MG/ML Injectable Solution	PSN	ef112633-e979-4933-b34b-e4d5756a90dc	2
966777	American cockroach allergenic extract 100 MG/ML Injectable Solution	SCD	ef112633-e979-4933-b34b-e4d5756a90dc	2
966709	American cockroach allergenic extract 20 MG/ML Injectable Solution	SCD	ef112633-e979-4933-b34b-e4d5756a90dc	2
905261	American cockroach allergenic extract 50 MG/ML Injectable Solution	SCD	ef112633-e979-4933-b34b-e4d5756a90dc	2
905261	American cockroach allergenic extract 0.05 GM/ML Injectable Solution	SY	ef112633-e979-4933-b34b-e4d5756a90dc	2
905261	Periplaneta americana allergenic extract 0.05 GM/ML Injectable Solution	SY	ef112633-e979-4933-b34b-e4d5756a90dc	2
966777	Periplaneta americana allergenic extract 0.1 GM/ML Injectable Solution	SY	ef112633-e979-4933-b34b-e4d5756a90dc	2
966777	Periplaneta americana allergenic extract 100 MG/ML Injectable Solution	SY	ef112633-e979-4933-b34b-e4d5756a90dc	2
966709	Periplaneta americana allergenic extract 20 MG/ML Injectable Solution	SY	ef112633-e979-4933-b34b-e4d5756a90dc	2
905261	Periplaneta americana allergenic extract 50 MG/ML Injectable Solution	SY	ef112633-e979-4933-b34b-e4d5756a90dc	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
49288-0148-1	49288014801	2 mL in 1 VIAL, MULTI-DOSE	2 ml	Historical
49288-0148-2	49288014802	5 mL in 1 VIAL, MULTI-DOSE	5 ml	Historical
49288-0148-3	49288014803	10 mL in 1 VIAL, MULTI-DOSE	10 ml	Historical
49288-0148-4	49288014804	30 mL in 1 VIAL, MULTI-DOSE	30 ml	Historical
49288-0148-5	49288014805	50 mL in 1 VIAL, MULTI-DOSE	50 ml	Historical