Short Ragweed

Product NDC: 49643-315
11-digit product format: 496430315
Labeler code: 49643
Product ID: 49643-315_2beeb52f-4452-7e67-e063-6294a90a5477
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ambrosia artemisiifolia
Dosage form: INJECTION
Route: CUTANEOUS; INTRADERMAL; SUBCUTANEOUS
Labeler: Allermed Laboratories, Inc.
Application: BLA103113
Marketing category: BLA
Marketing start: 1982-03-22
Substance: AMBROSIA ARTEMISIIFOLIA POLLEN
Active strength: 1 g/10mL
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 20 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
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	49643-315-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49643-315-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49643-315-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49643-315-10	`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	49643-315-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	49643-315-50	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	49643-315-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	49643-315-10	`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	49643-315-05	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	49643-315-50	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	49643-315-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	49643-315-10	`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	49643-315-05	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	49643-315-50	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	49643-315-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	49643-315-10	`1332a3947898…`	`d4bfe170f9cd…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMBROSIA ARTEMISIIFOLIA POLLEN	1 g/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K20Y81ACO3	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
896140	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
1482f8a2-c2c0-45a1-8e90-b427227f0b28	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
49643-315-05	2024-09-11	ALLERGENIC EXTRACT Standardized Short Ragweed
49643-315-10	2024-09-11	ALLERGENIC EXTRACT Standardized Short Ragweed
49643-315-30	2024-09-11	ALLERGENIC EXTRACT Standardized Short Ragweed
49643-315-50	2024-09-11	ALLERGENIC EXTRACT Standardized Short Ragweed
49643-315-05	2023-01-30	ALLERGENIC EXTRACT Standardized Short Ragweed
49643-315-10	2023-01-30	ALLERGENIC EXTRACT Standardized Short Ragweed
49643-315-30	2023-01-30	ALLERGENIC EXTRACT Standardized Short Ragweed
49643-315-50	2023-01-30	ALLERGENIC EXTRACT Standardized Short Ragweed

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49643-315-05	Short Ragweed	5 mL in 1 VIAL, MULTI-DOSE	INJECTION	5	6
49643-315-10	Short Ragweed	10 mL in 1 VIAL, MULTI-DOSE	INJECTION	10	6
49643-315-30	Short Ragweed	30 mL in 1 VIAL, MULTI-DOSE	INJECTION	30	6
49643-315-50	Short Ragweed	50 mL in 1 VIAL, MULTI-DOSE	INJECTION	50	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMBROSIA ARTEMISIIFOLIA POLLEN	ACTIVE INGREDIENT	K20Y81ACO3	SHORT RAGWEED (AMBROSIA ARTEMISIIFOLIA) INJECTION [ALLERMED LABORATORIES, INC.]	1
AMBROSIA ARTEMISIIFOLIA POLLEN	ACTIVE MOIETY	K20Y81ACO3	SHORT RAGWEED (AMBROSIA ARTEMISIIFOLIA) INJECTION [ALLERMED LABORATORIES, INC.]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	SHORT RAGWEED (AMBROSIA ARTEMISIIFOLIA) INJECTION [ALLERMED LABORATORIES, INC.]	1
Phenol	INACTIVE INGREDIENT	339NCG44TV	SHORT RAGWEED (AMBROSIA ARTEMISIIFOLIA) INJECTION [ALLERMED LABORATORIES, INC.]	1
Sodium bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	SHORT RAGWEED (AMBROSIA ARTEMISIIFOLIA) INJECTION [ALLERMED LABORATORIES, INC.]	1
Sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	SHORT RAGWEED (AMBROSIA ARTEMISIIFOLIA) INJECTION [ALLERMED LABORATORIES, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	SHORT RAGWEED (AMBROSIA ARTEMISIIFOLIA) INJECTION [ALLERMED LABORATORIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49643-315	SHORT RAGWEED (AMBROSIA ARTEMISIIFOLIA) INJECTION [ALLERMED LABORATORIES, INC.]	5	Current NDC, Legacy NDC, 4 package rows	20240913_1482f8a2-c2c0-45a1-8e90-b427227f0b28.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
Short Ragweed	AMBROSIA ARTEMISIIFOLIA	Allermed Laboratories, Inc.	1482f8a2-c2c0-45a1-8e90-b427227f0b28	2025-01-17	Warnings, Adverse reactions	Exact identifier application number: BLA103113 ndc (product): 49643-315

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103113		Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia	351(a)	Rx	2026-07-01

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
K20Y81ACO3	AMBROSIA ARTEMISIIFOLIA POLLEN	AMBROSIA ARTEMISIIFOLIA POLLEN
9W34L2CQ9A	AMBROSIA ARTEMISIIFOLIA	Ambrosia artemisiifolia

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
896140	short ragweed pollen extract 100 MG/ML Injectable Solution	PSN	1482f8a2-c2c0-45a1-8e90-b427227f0b28	6
896140	short ragweed pollen extract 100 MG/ML Injectable Solution	SCD	1482f8a2-c2c0-45a1-8e90-b427227f0b28	6
896140	Ambrosia artemisiifolia pollen extract 1 GM per 10 ML Injectable Solution	SY	1482f8a2-c2c0-45a1-8e90-b427227f0b28	6
896140	Ambrosia artemisiifolia pollen extract 100 MG/ML Injectable Solution	SY	1482f8a2-c2c0-45a1-8e90-b427227f0b28	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49643-315-05	49643031505	5 mL in 1 VIAL, MULTI-DOSE (49643-315-05)	5 ml	1982-03-22	0000-00-00	No	No	Current
49643-315-10	49643031510	10 mL in 1 VIAL, MULTI-DOSE (49643-315-10)	10 ml	1982-03-22	0000-00-00	No	No	Current
49643-315-30	49643031530	30 mL in 1 VIAL, MULTI-DOSE (49643-315-30)	30 ml	1982-03-22	0000-00-00	No	No	Current
49643-315-50	49643031550	50 mL in 1 VIAL, MULTI-DOSE (49643-315-50)	50 ml	1982-03-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ALLERGENIC EXTRACT Standardized Short Ragweed	Allermed Laboratories, Inc.	2025-01-17	HUMAN PRESCRIPTION DRUG LABEL	6