Treatment Set TS334972

Product NDC: 49288-0776
11-digit product format: 492880776
Labeler code: 49288
Product ID: 49288-0776_620f9cd6-e5b8-4036-a2dd-388186abade3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Treatment Set TS334972
Dosage form: INJECTION, SOLUTION
Route: INTRADERMAL; SUBCUTANEOUS
Labeler: Antigen Laboratories, Inc.
Application: BLA102223
Marketing category: BLA
Marketing start: 1986-10-31
Marketing end: 0000-00-00
Substance: AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; PLANTAGO LANCEOLATA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; FRAXINUS AMERICANA POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; POA PRATENSIS POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN
Active strength: 0 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL
Pharmacologic classes: Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated I...
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	49288-0776		I	Inactivated by FDA		2026-10-16
excluded package	package	49288-0776	49288-0776-3	I	Inactivated by FDA		2026-10-16

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 1 · 44 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	49288-0776-3	`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	49288-0776-3	`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	49288-0776-3	`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	49288-0776-3	`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	49288-0776-3	`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	49288-0776-3	`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	49288-0776-3	`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	49288-0776-3	`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	49288-0776-3	`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	49288-0776-3	`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	49288-0776-3	`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	49288-0776-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	49288-0776-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	49288-0776-3	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	49288-0776-3	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	49288-0776-3	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	49288-0776-3	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	49288-0776-3	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	49288-0776-3	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	49288-0776-3	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	49288-0776-3	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	49288-0776-3	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49288-0776-3	2019-10-21	C162847	48780-1	956f9ecf-d8e4-621f-e053-dbdaa90a74ad	ALLERGENIC EXTRACTS INDIVIDUAL TREATMENT VIAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49288-0776-3	Treatment Set TS334972	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACER NEGUNDO POLLEN	ACTIVE INGREDIENT	P6K070AR8V	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
AMARANTHUS RETROFLEXUS POLLEN	ACTIVE INGREDIENT	73B14PX5FW	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
BETULA NIGRA POLLEN	ACTIVE INGREDIENT	93963RFO1P	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
CARYA ALBA POLLEN	ACTIVE INGREDIENT	G2A764T54B	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
CARYA ILLINOINENSIS POLLEN	ACTIVE INGREDIENT	PYO4JR720Y	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
CYNODON DACTYLON POLLEN	ACTIVE INGREDIENT	175F461W10	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
FRAXINUS AMERICANA POLLEN	ACTIVE INGREDIENT	G684LX721Q	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
JUNIPERUS VIRGINIANA POLLEN	ACTIVE INGREDIENT	PY0JA16R2G	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
PLANTAGO LANCEOLATA POLLEN	ACTIVE INGREDIENT	DO87T1U2CI	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
POA PRATENSIS POLLEN	ACTIVE INGREDIENT	SCB8J7LS3T	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
POPULUS DELTOIDES POLLEN	ACTIVE INGREDIENT	476DVV63WP	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
QUERCUS ALBA POLLEN	ACTIVE INGREDIENT	Z4Y9ZSV4KK	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
SALSOLA KALI POLLEN	ACTIVE INGREDIENT	2MH135KC6G	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
SORGHUM HALEPENSE POLLEN	ACTIVE INGREDIENT	577VA5B4HP	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
ULMUS AMERICANA POLLEN	ACTIVE INGREDIENT	89BAT511BD	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
ACER NEGUNDO POLLEN	ACTIVE MOIETY	P6K070AR8V	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
AMARANTHUS RETROFLEXUS POLLEN	ACTIVE MOIETY	73B14PX5FW	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
BETULA NIGRA POLLEN	ACTIVE MOIETY	93963RFO1P	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
CARYA ALBA POLLEN	ACTIVE MOIETY	G2A764T54B	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
CARYA ILLINOINENSIS POLLEN	ACTIVE MOIETY	PYO4JR720Y	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
CYNODON DACTYLON POLLEN	ACTIVE MOIETY	175F461W10	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
FRAXINUS AMERICANA POLLEN	ACTIVE MOIETY	G684LX721Q	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
JUNIPERUS VIRGINIANA POLLEN	ACTIVE MOIETY	PY0JA16R2G	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
PLANTAGO LANCEOLATA POLLEN	ACTIVE MOIETY	DO87T1U2CI	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
POA PRATENSIS POLLEN	ACTIVE MOIETY	SCB8J7LS3T	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
POPULUS DELTOIDES POLLEN	ACTIVE MOIETY	476DVV63WP	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
QUERCUS ALBA POLLEN	ACTIVE MOIETY	Z4Y9ZSV4KK	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
SALSOLA KALI POLLEN	ACTIVE MOIETY	2MH135KC6G	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
SORGHUM HALEPENSE POLLEN	ACTIVE MOIETY	577VA5B4HP	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
ULMUS AMERICANA POLLEN	ACTIVE MOIETY	89BAT511BD	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49288-0776	TREATMENT SET TS334972 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]	1	Legacy NDC, 1 package rows	20100309_d943227b-3731-4e18-91a9-d84184c77d2c.zip

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
73B14PX5FW	AMARANTHUS RETROFLEXUS POLLEN	AMARANTHUS RETROFLEXUS POLLEN
2MH135KC6G	SALSOLA KALI POLLEN	SALSOLA KALI POLLEN
DO87T1U2CI	PLANTAGO LANCEOLATA POLLEN	PLANTAGO LANCEOLATA POLLEN
PYO4JR720Y	CARYA ILLINOINENSIS POLLEN	CARYA ILLINOINENSIS POLLEN
G2A764T54B	CARYA ALBA POLLEN	CARYA ALBA POLLEN
PY0JA16R2G	JUNIPERUS VIRGINIANA POLLEN	JUNIPERUS VIRGINIANA POLLEN
P6K070AR8V	ACER NEGUNDO POLLEN	ACER NEGUNDO POLLEN
G684LX721Q	FRAXINUS AMERICANA POLLEN	FRAXINUS AMERICANA POLLEN
89BAT511BD	ULMUS AMERICANA POLLEN	ULMUS AMERICANA POLLEN
Z4Y9ZSV4KK	QUERCUS ALBA POLLEN	QUERCUS ALBA POLLEN
93963RFO1P	BETULA NIGRA POLLEN	BETULA NIGRA POLLEN
SCB8J7LS3T	POA PRATENSIS POLLEN	POA PRATENSIS POLLEN
175F461W10	CYNODON DACTYLON POLLEN	CYNODON DACTYLON POLLEN
577VA5B4HP	SORGHUM HALEPENSE POLLEN	SORGHUM HALEPENSE POLLEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
49288-0776-3	49288077603	10 mL in 1 VIAL, MULTI-DOSE	10 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ALLERGENIC EXTRACTS INDIVIDUAL TREATMENT VIAL	Antigen Laboratories, Inc.	2010-03-08	HUMAN PRESCRIPTION DRUG LABEL	1