MELALEUCA

Product NDC: 0268-1277
11-digit product format: 002681277
Labeler code: 0268
Product ID: 0268-1277_4d458dd3-8f4a-4fbc-bdab-1be92ad1a7f4
Type: NON-STANDARDIZED ALLERGENIC
Nonproprietary name: MELALEUCA QUINQUENERVIA POLLEN
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: ALK-Abello, Inc.
Application: BLA103753
Marketing category: BLA
Marketing start: 1965-01-01
Substance: MELALEUCA QUINQUENERVIA POLLEN
Active strength: .05 g/mL
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], 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: MELALEUCA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MELALEUCA QUINQUENERVIA 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
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
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
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0268-1277-10	MELALEUCA	10 mL in 1 VIAL	INJECTION, SOLUTION	10		6
0268-1277-50	MELALEUCA	53 mL in 1 VIAL	INJECTION, SOLUTION	53		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0268-1277-10	ML - Milliliter	0268-1277	5bd80ec3-3a5f-4468-a252-a50792f37507	1	2016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0268-1277	FIRE ANT (SOLENOPSIS INVICTA) INJECTION, SOLUTION CURVULARIA (CURVULARIA INAEQUALIS) INJECTION, SOLUTION LENSCALE (ATRIPLEX LENTIFORMIS POLLEN) INJECTION, SOLUTION MOSQUITO (CULEX PIPIENS) INJECTION, SOLUTION MIXED COCKROACH (BLATTELLA GERMANICA AND PERIPLANETA AMERICANA) INJECTION, SOLUTION MELALEUCA (MELALEUCA QUINQUENERVIA POLLEN) INJECTION, SOLUTION SORREL/DOCK MIX (RUMEX ACETOSELLA POLLEN AND RUMEX CRISPUS POLLEN) INJECTION, SOLUTION MIXED RAGWEED (AMBROSIA ARTEMISIIFOLIA AND AMBROSIA TRIFIDA POLLEN) INJECTION, SOLUTION SHAGBARK, HICKORY (CARYA OVATA POLLEN) INJECTION, SOLUTION [ALK-ABELLO, INC.]	6	Current NDC, Legacy NDC, 1 package rows	20230601_6eed4dc3-8238-4487-bc98-b709defea665.zip
0268-1277	DANDELION (TARAXACUM OFFICINALE POLLEN) INJECTION, SOLUTION FIRE ANT (SOLENOPSIS INVICTA) INJECTION, SOLUTION MELALEUCA (MELALEUCA QUINQUENERVIA POLLEN) INJECTION, SOLUTION NETTLE (URTICA DIOICA POLLEN) INJECTION, SOLUTION SHAGBARK HICKORY (CARYA OVATA POLLEN) INJECTION, SOLUTION [ALK-ABELLO, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20200219_f35c70c4-fc50-466a-878b-3468358a28d5.zip

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
NX974IRT8E	MELALEUCA QUINQUENERVIA POLLEN	MELALEUCA QUINQUENERVIA 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	6eed4dc3-8238-4487-bc98-b709defea665	6
903916	broad leaved paperbark pollen extract 50 MG/ML Injectable Solution	PSN	6eed4dc3-8238-4487-bc98-b709defea665	6
999443	Curvularia inequalis allergenic extract 20000 UNT/ML Injectable Solution	PSN	6eed4dc3-8238-4487-bc98-b709defea665	6
1922790	giant ragweed pollen extract 20000 UNT/ML / short ragweed pollen extract 20000 UNT/ML Injectable Solution	PSN	6eed4dc3-8238-4487-bc98-b709defea665	6
852099	lens scale pollen extract 50 MG/ML Injectable Solution	PSN	6eed4dc3-8238-4487-bc98-b709defea665	6
968012	red imported fire ant allergenic extract 100 MG/ML Injectable Solution	PSN	6eed4dc3-8238-4487-bc98-b709defea665	6
899684	shagbark hickory pollen extract 100 MG/ML Injectable Solution	PSN	6eed4dc3-8238-4487-bc98-b709defea665	6
901487	sheep sorrel pollen extract 50 MG/ML / yellow dock pollen extract 50 MG/ML Injectable Solution	PSN	6eed4dc3-8238-4487-bc98-b709defea665	6
1735534	American cockroach allergenic extract 50 MG/ML / German cockroach allergenic extract 50 MG/ML Injectable Solution	SCD	6eed4dc3-8238-4487-bc98-b709defea665	6
903916	broad leaved paperbark pollen extract 50 MG/ML Injectable Solution	SCD	6eed4dc3-8238-4487-bc98-b709defea665	6
999443	Curvularia inequalis allergenic extract 20000 UNT/ML Injectable Solution	SCD	6eed4dc3-8238-4487-bc98-b709defea665	6
1922790	giant ragweed pollen extract 20000 UNT/ML / short ragweed pollen extract 20000 UNT/ML Injectable Solution	SCD	6eed4dc3-8238-4487-bc98-b709defea665	6
852099	lens scale pollen extract 50 MG/ML Injectable Solution	SCD	6eed4dc3-8238-4487-bc98-b709defea665	6
968012	red imported fire ant allergenic extract 100 MG/ML Injectable Solution	SCD	6eed4dc3-8238-4487-bc98-b709defea665	6
899684	shagbark hickory pollen extract 100 MG/ML Injectable Solution	SCD	6eed4dc3-8238-4487-bc98-b709defea665	6
901487	sheep sorrel pollen extract 50 MG/ML / yellow dock pollen extract 50 MG/ML Injectable Solution	SCD	6eed4dc3-8238-4487-bc98-b709defea665	6
1922790	Ambrosia artemisiifolia pollen extract 20000 PNU/ML / Ambrosia trifida pollen extract 20000 PNU/ML Injectable Solution	SY	6eed4dc3-8238-4487-bc98-b709defea665	6
1922790	Ambrosia artemisiifolia pollen extract 20000 UNT/ML / Ambrosia trifida pollen extract 20000 UNT/ML Injectable Solution	SY	6eed4dc3-8238-4487-bc98-b709defea665	6
852099	Atriplex lentiformis pollen extract 0.05 GM/ML Injectable Solution	SY	6eed4dc3-8238-4487-bc98-b709defea665	6
852099	Atriplex lentiformis pollen extract 50 MG/ML Injectable Solution	SY	6eed4dc3-8238-4487-bc98-b709defea665	6
899684	Carya ovata pollen extract 0.1 GM/ML Injectable Solution	SY	6eed4dc3-8238-4487-bc98-b709defea665	6
899684	Carya ovata pollen extract 100 MG/ML Injectable Solution	SY	6eed4dc3-8238-4487-bc98-b709defea665	6
999443	Curvularia inaequalis extract 20,000 UNT/ML Injectable Solution	SY	6eed4dc3-8238-4487-bc98-b709defea665	6
903916	Melaleuca quinquenervia pollen extract 0.05 GM/ML Injectable Solution	SY	6eed4dc3-8238-4487-bc98-b709defea665	6
903916	Melaleuca quinquenervia pollen extract 1:20 Injectable Solution	SY	6eed4dc3-8238-4487-bc98-b709defea665	6
903916	Melaleuca quinquenervia pollen extract 50 MG/ML Injectable Solution	SY	6eed4dc3-8238-4487-bc98-b709defea665	6
1735534	Periplaneta americana allergenic extract 0.05 GM/ML / Blatella germanica allergenic extract 0.05 GM/ML Injectable Solution	SY	6eed4dc3-8238-4487-bc98-b709defea665	6
903916	punktree pollen extract 50 MG/ML Injectable Solution	SY	6eed4dc3-8238-4487-bc98-b709defea665	6
901487	Rumex acetosella pollen extract 0.05 GM / Rumex crispus pollen extract 0.05 GM per ML Injectable Solution	SY	6eed4dc3-8238-4487-bc98-b709defea665	6
901487	Rumex acetosella pollen extract 50 MG / Rumex crispus pollen extract 50 MG per ML Injectable Solution	SY	6eed4dc3-8238-4487-bc98-b709defea665	6
968012	Solenopsis invicta allergenic extract 0.1 GM/ML Injectable Solution	SY	6eed4dc3-8238-4487-bc98-b709defea665	6
968012	Solenopsis invicta allergenic extract 100 MG/ML Injectable Solution	SY	6eed4dc3-8238-4487-bc98-b709defea665	6
903916	broad leaved paperbark pollen extract 50 MG/ML Injectable Solution	PSN	f35c70c4-fc50-466a-878b-3468358a28d5	3
852082	dandelion pollen extract 50 MG/ML Injectable Solution	PSN	f35c70c4-fc50-466a-878b-3468358a28d5	3
852049	nettle pollen extract 50 MG/ML Injectable Solution	PSN	f35c70c4-fc50-466a-878b-3468358a28d5	3
968004	red imported fire ant allergenic extract 50 MG/ML Injectable Solution	PSN	f35c70c4-fc50-466a-878b-3468358a28d5	3
852224	shagbark hickory pollen extract 50 MG/ML Injectable Solution	PSN	f35c70c4-fc50-466a-878b-3468358a28d5	3
903916	broad leaved paperbark pollen extract 50 MG/ML Injectable Solution	SCD	f35c70c4-fc50-466a-878b-3468358a28d5	3
852082	dandelion pollen extract 50 MG/ML Injectable Solution	SCD	f35c70c4-fc50-466a-878b-3468358a28d5	3
852049	nettle pollen extract 50 MG/ML Injectable Solution	SCD	f35c70c4-fc50-466a-878b-3468358a28d5	3
968004	red imported fire ant allergenic extract 50 MG/ML Injectable Solution	SCD	f35c70c4-fc50-466a-878b-3468358a28d5	3
852224	shagbark hickory pollen extract 50 MG/ML Injectable Solution	SCD	f35c70c4-fc50-466a-878b-3468358a28d5	3
852224	Carya ovata pollen extract 0.05 GM/ML Injectable Solution	SY	f35c70c4-fc50-466a-878b-3468358a28d5	3
852224	Carya ovata pollen extract 50 MG/ML Injectable Solution	SY	f35c70c4-fc50-466a-878b-3468358a28d5	3
903916	Melaleuca quinquenervia pollen extract 0.05 GM/ML Injectable Solution	SY	f35c70c4-fc50-466a-878b-3468358a28d5	3
903916	Melaleuca quinquenervia pollen extract 1:20 Injectable Solution	SY	f35c70c4-fc50-466a-878b-3468358a28d5	3
903916	Melaleuca quinquenervia pollen extract 50 MG/ML Injectable Solution	SY	f35c70c4-fc50-466a-878b-3468358a28d5	3
903916	punktree pollen extract 50 MG/ML Injectable Solution	SY	f35c70c4-fc50-466a-878b-3468358a28d5	3
968004	red imported fire ant allergenic extract 0.05 GM/ML Injectable Solution	SY	f35c70c4-fc50-466a-878b-3468358a28d5	3
968004	Solenopsis invicta allergenic extract 0.05 GM/ML Injectable Solution	SY	f35c70c4-fc50-466a-878b-3468358a28d5	3
968004	Solenopsis invicta allergenic extract 50 MG/ML Injectable Solution	SY	f35c70c4-fc50-466a-878b-3468358a28d5	3
852082	Taraxacum officinale pollen extract 0.05 GM/ML Injectable Solution	SY	f35c70c4-fc50-466a-878b-3468358a28d5	3
852082	Taraxacum officinale pollen extract 50 MG/ML Injectable Solution	SY	f35c70c4-fc50-466a-878b-3468358a28d5	3
852049	Urtica dioica pollen extract 0.05 GM/ML Injectable Solution	SY	f35c70c4-fc50-466a-878b-3468358a28d5	3
852049	Urtica dioica pollen extract 50 MG/ML Injectable Solution	SY	f35c70c4-fc50-466a-878b-3468358a28d5	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0268-1277-10	00268127710	10 mL in 1 VIAL (0268-1277-10)	10 ml	1965-01-01	0000-00-00	No	No	Current
0268-1277-50	00268127750	53 mL in 1 VIAL (0268-1277-50)	53 ml	1965-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
THERAPEUTIC ALLERGENIC EXTRACTS	ALK-Abello, Inc.	2023-05-25	NON-STANDARDIZED ALLERGENIC LABEL	6
Non-Standardized Single Glycerinated Therapeutic	ALK-Abello, Inc.	2020-02-21	NON-STANDARDIZED ALLERGENIC LABEL	3

MELALEUCA

Additional Listing Data#

Active Ingredients#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#