FDA.reportPublic FDA data

NDC 0378-9671-64 - Ipratropium Bromide and Albuterol Sulfate

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
0378-9671
Requested NDC
0378-9671-64
Package NDCs from labels
0378-9671-31, 0378-9671-93, 0378-9671-64, 0378-9671-30, 0378-9671-60
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2018-12-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ipratropium Bromide and Albuterol Sulfate - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2018-12-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-9671-30Ipratropium Bromide and Albuterol Sulfate1 in 1 CARTONSOLUTION17
0378-9671-31Ipratropium Bromide and Albuterol Sulfate3 mL in 1 AMPULESOLUTION37
0378-9671-31Ipratropium Bromide and Albuterol Sulfate1 in 1 POUCHSOLUTION17
0378-9671-60Ipratropium Bromide and Albuterol Sulfate30 in 1 POUCHSOLUTION307
0378-9671-60Ipratropium Bromide and Albuterol Sulfate2 in 1 CARTONSOLUTION27
0378-9671-64Ipratropium Bromide and Albuterol Sulfate30 in 1 POUCHSOLUTION307
0378-9671-64Ipratropium Bromide and Albuterol Sulfate3 mL in 1 AMPULESOLUTION37
0378-9671-93Ipratropium Bromide and Albuterol Sulfate30 in 1 CARTONSOLUTION307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-9671IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 8 package rows20190514_23c05e9a-9df5-4978-8831-cf562aa4ba92.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-9671-30ML - Milliliter0378-9671fecf8d7a-ca63-4086-a192-cfe09593da7f12016-03-04
0378-9671-31ML - Milliliter0378-9671441e8202-3014-467f-839f-1cb56dd1ff5a12015-05-05
0378-9671-58ML - Milliliter0378-9671e0ed7cbb-725f-41b4-98a8-8e4fbac96aa512013-10-17
0378-9671-60ML - Milliliter0378-9671ac7fec3f-8285-492f-b246-26b74402bbb712016-04-04
0378-9671-91ML - Milliliter0378-967132a69a83-77f5-460b-ac59-cdb79109616712014-04-03
0378-9671-93ML - Milliliter0378-9671f9a81245-211d-421f-9a2b-9b034708627c12013-07-02
0378-9671-98ML - Milliliter0378-9671d5fa01b8-04ef-4d82-bc9d-1bc4f51852f712015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Albuterol SulfateACTIVE INGREDIENT021SEF3731IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]1
Ipratropium BromideACTIVE INGREDIENTJ697UZ2A9JIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]1
AlbuterolACTIVE MOIETYQF8SVZ843EIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]1
IpratropiumACTIVE MOIETYGR88G0I6ULIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RIPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]1

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 8 of 8 · 155 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Albuterol SulfateALBUTEROL SULFATEAsclemed USA, Inc.87ff8be7-3a49-44bd-92de-eb8db24af95b2022-12-13Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
ALBUTEROL SULFATEALBUTEROL SULFATEHF Acquisition Co LLC, DBA HealthFirstad299502-8779-d280-e053-2995a90a73712022-12-10Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Ipratropium Bromide and Albuterol SulfateIPRATROPIUM BROMIDE AND ALBUTEROL SULFATEProficient Rx LP0b0587df-b4bd-4fae-9d79-c71362c0314b2022-12-01Warnings, Adverse reactionsExact identifier
rxcui: 1437702
unii: J697UZ2A9J
unii: 021SEF3731
albuterol sulfateALBUTEROL SULFATEProficient Rx LP918551c7-c3c1-43bc-b575-b33fdb4e96fc2022-12-01Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEProficient Rx LPd3d2ab1e-8f91-4a4d-aa6b-5a57f59ad56b2022-11-01Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Ipratropium BromideIPRATROPIUM BROMIDEHikma Pharmaceuticals USA Inc.71bdbbb9-8696-416d-bed4-7259929c01612022-07-01Warnings, Adverse reactionsExact identifier
unii: J697UZ2A9J
Ipratropium BromideIPRATROPIUM BROMIDEHikma Pharmaceuticals USA Inc.05c56190-e346-4674-a4f8-049ce632ce2d2022-07-01Exact identifier
unii: J697UZ2A9J
Ipratropium BromideIPRATROPIUM BROMIDESun Pharmaceutical Industries, Inc.231ae8f2-1ec9-4e0f-90a8-11d7b62225762022-04-13Warnings, Adverse reactionsExact identifier
unii: J697UZ2A9J
AlbuterolALBUTEROLProficient Rx LP895dff1c-d21c-4470-b021-a5b68364c1ec2022-04-01Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
ALBUTEROL SULFATEALBUTEROL SULFATEExelan Pharmaceuticals, Inc.29e35e54-dbd6-4426-993f-893d7a4d69be2022-02-10Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEAsclemed USA, Inc.8153d82c-b5c5-4aa2-bce5-b69cf2d23f5d2020-10-16Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Ipratropium BromideIPRATROPIUM BROMIDEBausch & Lomb Incorporated3fd850a2-af0f-4291-af5d-52c8d6094e642019-05-01Warnings, Adverse reactionsExact identifier
unii: J697UZ2A9J
Ipratropium bromideIPRATROPIUM BROMIDEBausch & Lomb Incorporated1e92b86d-66e1-45e4-9e23-f9310c95bf822019-05-01Warnings, Adverse reactionsExact identifier
unii: J697UZ2A9J
Ipratropium Bromide and Albuterol SulfateIPRATROPIUM BROMIDE AND ALBUTEROL SULFATEMylan Pharmaceuticals Inc.23c05e9a-9df5-4978-8831-cf562aa4ba922018-12-12Warnings, Adverse reactionsExact identifier
application number: ANDA202496
ndc (package): 0378-9671-30
ndc (package): 0378-9671-60
ndc (package): 0378-9671-31
ndc (package): 0378-9671-93
ndc (package): 0378-9671-64
ndc (product): 0378-9671
ndc11 (package): 00378967164
rxcui: 1437702
spl id: 96603d2c-6783-4f6c-8b3e-de3eaabcc6aa
spl set id: 23c05e9a-9df5-4978-8831-cf562aa4ba92
unii: J697UZ2A9J
unii: 021SEF3731
Ipratropium BromideIPRATROPIUM BROMIDEMylan Pharmaceuticals Inc.f625d3e3-c175-4d9a-99ea-dab410b262f12013-06-24Warnings, Adverse reactionsExact identifier
unii: J697UZ2A9J

Reported adverse events (FAERS/openFDA)#

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