BIRCH MIX

Product NDC: 0268-8024
11-digit product format: 002688024
Labeler code: 0268
Product ID: 0268-8024_0521d788-9ddb-4e34-a990-62ccf60a4402
Type: NON-STANDARDIZED ALLERGENIC
Nonproprietary name: BETULA NIGRA POLLEN and BETULA POPULIFOLIA POLLEN
Dosage form: INJECTION, SOLUTION
Route: PERCUTANEOUS
Labeler: ALK-Abello, Inc.
Application: BLA103753
Marketing category: BLA
Marketing start: 1965-01-01
Substance: BETULA NIGRA POLLEN; BETULA POPULIFOLIA POLLEN
Active strength: .05; .05 g/mL; g/mL
Pharmacologic classes: Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BETULA NIGRA POLLEN	.05 g/mL
BETULA POPULIFOLIA POLLEN	.05 g/mL

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0268-8024-06	BIRCH MIX	5.5 mL in 1 VIAL	INJECTION, SOLUTION	5.5	11
0268-8024-10	BIRCH MIX	10.5 mL in 1 VIAL	INJECTION, SOLUTION	10.5	8
0268-8024-50	BIRCH MIX	53 mL in 1 VIAL	INJECTION, SOLUTION	53	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0268-8024	4 WEED MIX (AMARANTHUS RETROFLEXUS POLLEN, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN AND XANTHIUM STRUMARIUM POLLEN) INJECTION, SOLUTION 9 TREE MIX (ACER SACCHARUM POLLEN, ALNUS RHOMBIFOLIA POLLEN, BETULA LENTA POLLEN, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS ALBA POLLEN, QUERCUS ALBA POLLEN AND ULMUS CRASSIFOLIA POLLEN) INJECTION, SOLUTION BIRCH MIX (BETULA NIGRA POLLEN AND BETULA POPULIFOLIA POLLEN) INJECTION, SOLUTION HICKORY/ PECAN MIX (CARYA ILLINOINENSIS POLLEN AND CARYA OVATA POLLEN) INJECTION, SOLUTION MAPLE/BOX ELDER (ACER NEGUNDO POLLEN AND ACER SACCHARUM POLLEN) INJECTION, SOLUTION MAPLE MIX (ACER NEGUNDO POLLEN AND ACER RUBRUM POLLEN) INJECTION, SOLUTION MIXED COCKROACH (BLATELLA GERMANICA AND PERIPLANETA AMERICANA) INJECTION, SOLUTION MIXED FEATHERS (ANAS PLATYRHYNCHOS FEATHER, ANSER ANSER FEATHER AND GALLUS GALLUS FEATHER) INJECTION, SOLUTION MIXED WEEDS (CHENOPODIUM ALBUM POLLEN, IVA ANNUA POLLEN, PLANTAGO LANCEOLATA POLLEN AND XANTHIUM STR	11	Current NDC, Legacy NDC, 1 package rows	20230308_c7c0bc70-b640-4d1d-ac14-ade0fd8b8575.zip
0268-8024	MIXED ASPERGILLUS (ASPERGILLUS NIGER, ASPERGILLUS REPENS, ASPERGILLUS ORYZAE, ASPERGILLUS TERREUS) INJECTION, SOLUTION MIXED FEATHERS (GALLUS GALLUS FEATHER, ANAS PLATYRHYNCHOS FEATHER, ANSER ANSER FEATHER) INJECTION, SOLUTION MIXED MOLDS (ALTERNARIA ALTERNATA, CLADOSPORIUM SPHAEROSPERMUM, ASPERGILLUS NIGER, ASPERGILLUS REPENS, ASPERGILLUS ORYZAE, ASPERGILLUS TERREUS, PENICILLIUM CHRYSOGENUM, PENICILLIUM NOTATUM) INJECTION, SOLUTION MIXED PENICILLIUM (PENICILLIUM CHRYSOGENUM, PENICILLIUM NOTATUM) INJECTION, SOLUTION 10 TREE MIX (ACER NEGUNDO POLLEN, BETULA NIGRA POLLEN, BLACK WALNUT, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN, QUERCUS RUBRA POLLEN, SALIX NIGRA POLLEN AND ULMUS AMERICANA POLLEN) INJECTION, SOLUTION 4 WEED MIX (AMARANTHUS RETROFLEXUS POLLEN, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN, XANTHIUM STRUMARIUM POLLEN) INJECTION, SOLUTION BIRCH MIX (BETULA NIGRA, BETULA POPULIFOLIA) INJECTION, SOLUTION [ALK-ABELLO,	8	Current NDC, Legacy NDC, 2 package rows	20230602_1f7f1612-c7b2-4948-b35b-fcaa92de8989.zip

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
93963RFO1P	BETULA NIGRA POLLEN	BETULA NIGRA POLLEN
23H70FYJ5U	BETULA POPULIFOLIA POLLEN	BETULA POPULIFOLIA POLLEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1735534	American cockroach allergenic extract 50 MG/mL / German cockroach allergenic extract 50 MG/mL Injectable Solution	PSN	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852165	black willow pollen extract 50 MG/ML Injectable Solution	PSN	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
2171890	box elder maple pollen extract 50 MG/mL / hard maple pollen extract 50 MG/mL Injectable Solution	PSN	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927623	box elder maple pollen extract 50 MG/ML / red maple pollen extract 50 MG/ML Injectable Solution	PSN	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852082	dandelion pollen extract 50 MG/ML Injectable Solution	PSN	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927658	gray birch pollen extract 50 MG/ML / river birch pollen extract 50 MG/ML Injectable Solution	PSN	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852049	nettle pollen extract 50 MG/ML Injectable Solution	PSN	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927683	pecan pollen extract 50 MG/ML / shagbark hickory pollen extract 50 MG/ML Injectable Solution	PSN	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
896138	short ragweed pollen extract 50 MG/ML Injectable Solution	PSN	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1735534	American cockroach allergenic extract 50 MG/ML / German cockroach allergenic extract 50 MG/ML Injectable Solution	SCD	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852165	black willow pollen extract 50 MG/ML Injectable Solution	SCD	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
2171890	box elder maple pollen extract 50 MG/ML / hard maple pollen extract 50 MG/ML Injectable Solution	SCD	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927623	box elder maple pollen extract 50 MG/ML / red maple pollen extract 50 MG/ML Injectable Solution	SCD	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852082	dandelion pollen extract 50 MG/ML Injectable Solution	SCD	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927658	gray birch pollen extract 50 MG/ML / river birch pollen extract 50 MG/ML Injectable Solution	SCD	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852049	nettle pollen extract 50 MG/ML Injectable Solution	SCD	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927683	pecan pollen extract 50 MG/ML / shagbark hickory pollen extract 50 MG/ML Injectable Solution	SCD	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
896138	short ragweed pollen extract 50 MG/ML Injectable Solution	SCD	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927623	Acer negundo pollen extract 0.05 GM/ML / Acer rubrum pollen extract 0.05 GM/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
2171890	Acer negundo pollen extract 0.05 GM/ML / Acer saccharum pollen extract 0.05 GM/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927623	Acer negundo pollen extract 50 MG/ML / Acer rubrum pollen extract 50 MG/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
2171890	Acer negundo pollen extract 50 MG/ML / Acer saccharum pollen extract 50 MG/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
896138	Ambrosia artemisiifolia pollen extract 0.05 GM/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
896138	Ambrosia artemisiifolia pollen extract 50 MG/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927658	Betula nigra pollen extract 0.05 GM/ML / Betula populifolia pollen extract 0.05 GM/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927658	Betula nigra pollen extract 50 MG/ML / Betula populifolia pollen extract 50 MG/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852165	black willow pollen extract 0.05 GM/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927683	Carya illinoinensis pollen 0.05 GM/ML / Carya ovata pollen extract 0.05 GM/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927683	Carya illinoinensis pollen 50 MG/ML / Carya ovata pollen extract 50 MG/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1735534	Periplaneta americana allergenic extract 0.05 GM/ML / Blatella germanica allergenic extract 0.05 GM/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852165	Salix nigra pollen extract 0.05 GM/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852165	Salix nigra pollen extract 50 MG/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852082	Taraxacum officinale pollen extract 0.05 GM/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852082	Taraxacum officinale pollen extract 50 MG/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852049	Urtica dioica pollen extract 0.05 GM/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852049	Urtica dioica pollen extract 50 MG/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927658	gray birch pollen extract 50 MG/ML / river birch pollen extract 50 MG/ML Injectable Solution	PSN	1f7f1612-c7b2-4948-b35b-fcaa92de8989	8
966954	Penicillium chrysogenum var. chrysogenum allergenic extract 20,000 UNT/mL Injectable Solution	PSN	1f7f1612-c7b2-4948-b35b-fcaa92de8989	8
1927658	gray birch pollen extract 50 MG/ML / river birch pollen extract 50 MG/ML Injectable Solution	SCD	1f7f1612-c7b2-4948-b35b-fcaa92de8989	8
966954	Penicillium chrysogenum var. chrysogenum allergenic extract 20000 UNT/ML Injectable Solution	SCD	1f7f1612-c7b2-4948-b35b-fcaa92de8989	8
1927658	Betula nigra pollen extract 0.05 GM/ML / Betula populifolia pollen extract 0.05 GM/ML Injectable Solution	SY	1f7f1612-c7b2-4948-b35b-fcaa92de8989	8
1927658	Betula nigra pollen extract 50 MG/ML / Betula populifolia pollen extract 50 MG/ML Injectable Solution	SY	1f7f1612-c7b2-4948-b35b-fcaa92de8989	8
966954	Penicillium chrysogenum var. chrysogenum extract 20,000 UNT/ML Injectable Solution	SY	1f7f1612-c7b2-4948-b35b-fcaa92de8989	8
966954	Penicillium notatum allergenic extract 20,000 UNT/ML Injectable Solution	SY	1f7f1612-c7b2-4948-b35b-fcaa92de8989	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0268-8024-06	00268802406	5.5 mL in 1 VIAL (0268-8024-06)	5.5 ml	1965-01-01	0000-00-00	No	No	Current
0268-8024-10	00268802410	10.5 mL in 1 VIAL (0268-8024-10)	10.5 ml	1998-02-23	0000-00-00	No	No	Current
0268-8024-50	00268802450	53 mL in 1 VIAL (0268-8024-50)	53 ml	1998-02-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
THERAPEUTIC ALLERGENIC EXTRACTS- Glycerin Products	ALK-Abello, Inc.	2023-05-30	NON-STANDARDIZED ALLERGENIC LABEL	8
Scratch NonStandardized Products	ALK-Abello, Inc.	2023-03-10	NON-STANDARDIZED ALLERGENIC LABEL	11

BIRCH MIX

Additional Listing Data#

Active Ingredients#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#