Nigrospora sphaerica

Product NDC: 36987-2022
11-digit product format: 369872022
Labeler code: 36987
Product ID: 36987-2022_23e797dd-af20-4ed3-8c4d-eed59804742e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nigrospora sphaerica
Dosage form: INJECTION, SOLUTION
Route: INTRADERMAL; SUBCUTANEOUS
Labeler: Nelco Laboratories, Inc.
Application: BLA102192
Marketing category: BLA
Marketing start: 1972-08-29
Marketing end: 0000-00-00
Substance: KHUSKIA ORYZAE
Active strength: 20000 [PNU]/mL
Pharmacologic classes: Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	36987-2022		I	Inactivated by FDA	2026-08-03
excluded package	package	36987-2022	36987-2022-1	I	Inactivated by FDA	2026-08-03
excluded package	package	36987-2022	36987-2022-2	I	Inactivated by FDA	2026-08-03
excluded package	package	36987-2022	36987-2022-3	I	Inactivated by FDA	2026-08-03
excluded package	package	36987-2022	36987-2022-4	I	Inactivated by FDA	2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 110 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36987-2022-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36987-2022-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36987-2022-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36987-2022-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36987-2022-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36987-2022-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36987-2022-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36987-2022-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36987-2022-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36987-2022-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36987-2022-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36987-2022-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36987-2022-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36987-2022-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36987-2022-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36987-2022-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36987-2022-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36987-2022-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36987-2022-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36987-2022-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36987-2022-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36987-2022-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36987-2022-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36987-2022-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36987-2022-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36987-2022-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36987-2022-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36987-2022-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36987-2022-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36987-2022-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36987-2022-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36987-2022-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36987-2022-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36987-2022-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36987-2022-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36987-2022-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36987-2022-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36987-2022-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36987-2022-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36987-2022-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36987-2022-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36987-2022-4	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36987-2022-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36987-2022-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36987-2022-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36987-2022-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36987-2022-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36987-2022-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
36987-2022-1	Allergenic Extract
36987-2022-2	Allergenic Extract
36987-2022-3	Allergenic Extract
36987-2022-4	Allergenic Extract

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
36987-2022-1	Nigrospora sphaerica	5 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	5	1
36987-2022-2	Nigrospora sphaerica	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10	1
36987-2022-3	Nigrospora sphaerica	30 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	30	1
36987-2022-4	Nigrospora sphaerica	50 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	50	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
KHUSKIA ORYZAE	ACTIVE INGREDIENT	VK8C112WTS	NIGROSPORA SPHAERICA INJECTION, SOLUTION [NELCO LABORATORIES, INC.]	1
KHUSKIA ORYZAE	ACTIVE MOIETY	VK8C112WTS	NIGROSPORA SPHAERICA INJECTION, SOLUTION [NELCO LABORATORIES, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	NIGROSPORA SPHAERICA INJECTION, SOLUTION [NELCO LABORATORIES, INC.]	1
PHENOL	INACTIVE INGREDIENT	339NCG44TV	NIGROSPORA SPHAERICA INJECTION, SOLUTION [NELCO LABORATORIES, INC.]	1
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	NIGROSPORA SPHAERICA INJECTION, SOLUTION [NELCO LABORATORIES, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NIGROSPORA SPHAERICA INJECTION, SOLUTION [NELCO LABORATORIES, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	NIGROSPORA SPHAERICA INJECTION, SOLUTION [NELCO LABORATORIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36987-2022	NIGROSPORA SPHAERICA INJECTION, SOLUTION [NELCO LABORATORIES, INC.]	1	Legacy NDC, 4 package rows	20100106_cfe0440b-fd9e-413b-965c-0a7b5bfbba3c.zip

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
VK8C112WTS	KHUSKIA ORYZAE	KHUSKIA ORYZAE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
892481	Khuskia oryzae allergenic extract 20000 UNT/ML Injectable Solution	PSN	cfe0440b-fd9e-413b-965c-0a7b5bfbba3c	1
892481	Khuskia oryzae allergenic extract 20000 UNT/ML Injectable Solution	SCD	cfe0440b-fd9e-413b-965c-0a7b5bfbba3c	1
892481	Nigrospora sphaerica allergenic extract 20,000 UNT/ML Injectable Solution	SY	cfe0440b-fd9e-413b-965c-0a7b5bfbba3c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
36987-2022-1	36987202201	5 mL in 1 VIAL, MULTI-DOSE	5 ml	Historical
36987-2022-2	36987202202	10 mL in 1 VIAL, MULTI-DOSE	10 ml	Historical
36987-2022-3	36987202203	30 mL in 1 VIAL, MULTI-DOSE	30 ml	Historical
36987-2022-4	36987202204	50 mL in 1 VIAL, MULTI-DOSE	50 ml	Historical