Citric Buffered Normal Saline

Product NDC
72000-030
11-digit product format
720000030
Labeler code
72000
Product ID
72000-030_772b4b36-4627-4087-8a16-c1ed771939c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
anhydrous citric acid
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Nabriva Therapeutics US, Inc.
Application
NDA211673
Marketing category
NDA
Marketing start
2019-09-09
Marketing end
0000-00-00
Substance
ANHYDROUS CITRIC ACID
Active strength
166 mg/270mL
Pharmacologic classes
Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
b43cec0b-21e9-4d34-a794-f1d7b3d1f30dProduct name120200204
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72000-030-01Citric Buffered Normal Saline270 mL in 1 BAGINJECTION, SOLUTION2709
72000-030-06Citric Buffered Normal Saline6 in 1 CARTONINJECTION, SOLUTION69

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72000-030-01ML - Milliliter72000-030ba29e0ce-1f82-4fe4-bf76-56b490a40b8112019-10-07
72000-030-06ML - Milliliter72000-0303217de5e-71f1-4fa1-b2ff-7439fff9b8c812019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72000-030XENLETA (LEFAMULIN ACETATE) INJECTION, SOLUTION CITRIC BUFFERED NORMAL SALINE (ANHYDROUS CITRIC ACID) INJECTION, SOLUTION XENLETA (LEFAMULIN ACETATE) TABLET, COATED [NABRIVA THERAPEUTICS US, INC.]9Legacy NDC, 2 package rows20241013_101db63d-2fe2-48df-8506-1382d6dcd4a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2198948lefamulin 150 MG in 15 ML InjectionPSN101db63d-2fe2-48df-8506-1382d6dcd4a39
2198961lefamulin 600 MG Oral TabletPSN101db63d-2fe2-48df-8506-1382d6dcd4a39
2198953Xenleta 150 MG in 15 ML InjectionPSN101db63d-2fe2-48df-8506-1382d6dcd4a39
2198966Xenleta 600 MG Oral TabletPSN101db63d-2fe2-48df-8506-1382d6dcd4a39
219895315 ML lefamulin 10 MG/ML Injection [Xenleta]SBD101db63d-2fe2-48df-8506-1382d6dcd4a39
2198966lefamulin 600 MG Oral Tablet [Xenleta]SBD101db63d-2fe2-48df-8506-1382d6dcd4a39
219894815 ML lefamulin 10 MG/ML InjectionSCD101db63d-2fe2-48df-8506-1382d6dcd4a39
2198961lefamulin 600 MG Oral TabletSCD101db63d-2fe2-48df-8506-1382d6dcd4a39
219895315 ML Xenleta 10 MG/ML InjectionSY101db63d-2fe2-48df-8506-1382d6dcd4a39
2198948lefamulin 150 MG per 15 ML InjectionSY101db63d-2fe2-48df-8506-1382d6dcd4a39
2198953Xenleta 150 MG per 15 ML InjectionSY101db63d-2fe2-48df-8506-1382d6dcd4a39
2198966Xenleta 600 MG Oral TabletSY101db63d-2fe2-48df-8506-1382d6dcd4a39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72000-030-0172000003001270 mL in 1 BAG270 mlHistorical
72000-030-06720000030066 BAG in 1 CARTON (72000-030-06) > 270 mL in 1 BAG (72000-030-01) 6 bag2019-09-090000-00-00NoNoCurrent