NDC 0010-3827 - PromAce

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0010-3827
Package NDCs from labels: 0010-3827-01
Manufacturer: Boehringer Ingelheim Animal Health USA Inc.
Effective date: 2025-03-27
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
PromAce ® Injectable (acepromazine maleate injection)	Boehringer Ingelheim Animal Health USA Inc.	2025-03-27	PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0010-3827-01	PromAce	50 mL in 1 VIAL, MULTI-DOSE	INJECTION	50		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0010-3827	PROMACE (ACEPROMAZINE MALEATE) INJECTION [BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.]	8	1 package rows	20250330_11ee8981-46eb-4791-8e40-727c991341fe.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACEPROMAZINE MALEATE	ACTIVE INGREDIENT	37862HP2OM	PROMACE (ACEPROMAZINE MALEATE) INJECTION [BOEHRINGER INGELHEIM VETMEDICA, INC.]	3
ACEPROMAZINE	ACTIVE MOIETY	54EJ303F0R	PROMACE (ACEPROMAZINE MALEATE) INJECTION [BOEHRINGER INGELHEIM VETMEDICA, INC.]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	PROMACE (ACEPROMAZINE MALEATE) INJECTION [BOEHRINGER INGELHEIM VETMEDICA, INC.]	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	PROMACE (ACEPROMAZINE MALEATE) INJECTION [BOEHRINGER INGELHEIM VETMEDICA, INC.]	3
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	PROMACE (ACEPROMAZINE MALEATE) INJECTION [BOEHRINGER INGELHEIM VETMEDICA, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROMACE (ACEPROMAZINE MALEATE) INJECTION [BOEHRINGER INGELHEIM VETMEDICA, INC.]	3

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 16 of 16 · 305 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Homeoplex D	GLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,	Supplement Clinic, LLC.	cd6b48ab-3566-484d-8deb-15ef6f8e7e8f	2017-11-01	Warnings	Exact identifier unii: LKG8494WBH
Sterile Water	WATER	Baxter Healthcare Corporation	ef3e79c5-3f58-4b36-a296-64b7d9a651c1	2017-10-17	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eye Wash	WATER	CVS Pharmacy	049cee29-7ec2-4d5b-8308-f522acde43a7	2017-03-29	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Baxter Healthcare Company	210dc9ab-d6ca-4552-ac19-1be17792d290	2016-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	051f7347-5a76-4664-8fe2-e61b3dfcb0e4	2014-08-27		Exact identifier unii: XF417D3PSL unii: B22547B95K

Reported adverse events (FAERS/openFDA)#

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