FDA.reportPublic FDA data

Terbutaline Sulfate

Product NDC
71205-939
11-digit product format
712050939
Labeler code
71205
Product ID
71205-939_9f8ee6b8-61e1-478a-90de-57358fdb5905
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbutaline Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA211832
Marketing category
ANDA
Marketing start
2020-07-13
Substance
TERBUTALINE SULFATE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Terbutaline Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERBUTALINE SULFATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii576PU70Y8E
Rxcui857677, 857683

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
49ccb555-d142-0761-ee45-2e1304b37b1dProduct name220210111
a3c04a67-87ea-e8b8-0458-db8085ac6340Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-939-00Terbutaline Sulfate100 in 1 BOTTLETABLET1002
71205-939-30Terbutaline Sulfate30 in 1 BOTTLETABLET302
71205-939-55Terbutaline Sulfate500 in 1 BOTTLETABLET5002
71205-939-60Terbutaline Sulfate60 in 1 BOTTLETABLET602
71205-939-90Terbutaline Sulfate90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-939-00EA - Each71205-939fd9f84bc-5113-46c6-ae29-4bc7882c2e2512021-05-05
71205-939-30EA - Each71205-9396cfccf58-0d17-4f35-ac4e-dc71833c6e2812021-09-07
71205-939-55EA - Each71205-939dff2a3b3-9c5a-4592-bc98-abec8c505c0c12021-05-05
71205-939-60EA - Each71205-939ac7a965a-b6dd-4f58-a18a-2db6761cb65412021-05-05
71205-939-90EA - Each71205-9395a9d1753-a902-42fa-aff0-adeb5487521012021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-939TERBUTALINE SULFATE TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 5 package rows20220426_0a95bc4f-34d3-4b5e-841b-6839e1c1e0c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857677terbutaline sulfate 2.5 MG Oral TabletPSN0a95bc4f-34d3-4b5e-841b-6839e1c1e0c72
857683terbutaline sulfate 5 MG Oral TabletPSN0a95bc4f-34d3-4b5e-841b-6839e1c1e0c72
857677terbutaline sulfate 2.5 MG Oral TabletSCD0a95bc4f-34d3-4b5e-841b-6839e1c1e0c72
857683terbutaline sulfate 5 MG Oral TabletSCD0a95bc4f-34d3-4b5e-841b-6839e1c1e0c72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-939-0071205093900100 TABLET in 1 BOTTLE (71205-939-00) 100 tablet2020-11-190000-00-00NoNoCurrent
71205-939-307120509393030 TABLET in 1 BOTTLE (71205-939-30) 30 tablet2020-11-190000-00-00NoNoCurrent
71205-939-5571205093955500 TABLET in 1 BOTTLE (71205-939-55) 500 tablet2020-11-190000-00-00NoNoCurrent
71205-939-607120509396060 TABLET in 1 BOTTLE (71205-939-60) 60 tablet2020-11-190000-00-00NoNoCurrent
71205-939-907120509399090 TABLET in 1 BOTTLE (71205-939-90) 90 tablet2020-11-190000-00-00NoNoCurrent