FDA.reportPublic FDA data

prednisone

Product NDC
71205-741
11-digit product format
712050741
Labeler code
71205
Product ID
71205-741_d2de1afc-8e56-40f5-980f-f54e86aaaf68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA208412
Marketing category
ANDA
Marketing start
2021-09-01
Substance
PREDNISONE
Active strength
20 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
prednisone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui312615

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2205d503-be51-445b-bb34-c209cc557b3cProduct name520230105
9492a99d-61c8-491f-9086-1c6a7e98c040Product name620230105
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-741-07prednisone7 in 1 BOTTLE, PLASTICTABLET73
71205-741-10prednisone10 in 1 BOTTLE, PLASTICTABLET103
71205-741-14prednisone14 in 1 BOTTLE, PLASTICTABLET143
71205-741-15prednisone15 in 1 BOTTLE, PLASTICTABLET153
71205-741-18prednisone18 in 1 BOTTLE, PLASTICTABLET183
71205-741-20prednisone20 in 1 BOTTLE, PLASTICTABLET203
71205-741-21prednisone21 in 1 BOTTLE, PLASTICTABLET213
71205-741-30prednisone30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-741-10EA - Each71205-7416d119203-7cd9-4233-aa82-78cc0524ebf712023-06-06
71205-741-14EA - Each71205-741f3e7e40b-8368-4e50-8401-0a171f8905c412024-03-12
71205-741-15EA - Each71205-741dc27edf1-a309-4351-86a0-c618c3a070fb12023-06-06
71205-741-18EA - Each71205-741906811d1-3e41-46f2-9122-a3aee379e88212025-05-14
71205-741-20EA - Each71205-741944805d8-a026-4c5c-a3fc-7aac63ddbccb12023-06-06
71205-741-21EA - Each71205-741a6df89d5-6ca3-4966-9f93-e77e2dba7e0912023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-741PREDNISONE TABLET [PROFICIENT RX LP]2Current NDC, 8 package rows20241129_4b37ada5-1f22-46d5-a794-fd1477c0eb9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN4b37ada5-1f22-46d5-a794-fd1477c0eb9b3
312615prednisone 20 MG Oral TabletSCD4b37ada5-1f22-46d5-a794-fd1477c0eb9b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-741-07712050741077 TABLET in 1 BOTTLE, PLASTIC (71205-741-07) 7 tablet2026-04-30NoNoHistorical
71205-741-107120507411010 TABLET in 1 BOTTLE, PLASTIC (71205-741-10) 10 tablet2023-01-06NoNoHistorical
71205-741-147120507411414 TABLET in 1 BOTTLE, PLASTIC (71205-741-14) 14 tablet2023-01-06NoNoHistorical
71205-741-157120507411515 TABLET in 1 BOTTLE, PLASTIC (71205-741-15) 15 tablet2023-01-06NoNoHistorical
71205-741-187120507411818 TABLET in 1 BOTTLE, PLASTIC (71205-741-18) 18 tablet2024-11-20NoNoHistorical
71205-741-207120507412020 TABLET in 1 BOTTLE, PLASTIC (71205-741-20) 20 tablet2023-01-06NoNoHistorical
71205-741-217120507412121 TABLET in 1 BOTTLE, PLASTIC (71205-741-21) 21 tablet2023-01-06NoNoHistorical
71205-741-307120507413030 TABLET in 1 BOTTLE, PLASTIC (71205-741-30) 30 tablet2023-01-06NoNoHistorical