FDA.reportPublic FDA data

Prednisone

Product NDC
71205-421
11-digit product format
712050421
Labeler code
71205
Product ID
71205-421_8a428fc8-6e40-47cc-abc6-602c3aeb6bc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA211575
Marketing category
ANDA
Marketing start
2019-11-15
Substance
PREDNISONE
Active strength
10 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198145

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
71205-421-10Prednisone10 in 1 BOTTLETABLET109
71205-421-18Prednisone18 in 1 BOTTLETABLET189
71205-421-20Prednisone20 in 1 BOTTLETABLET209
71205-421-21Prednisone21 in 1 BOTTLETABLET219
71205-421-24Prednisone24 in 1 BOTTLETABLET249
71205-421-28Prednisone28 in 1 BOTTLETABLET289
71205-421-30Prednisone30 in 1 BOTTLETABLET309
71205-421-40Prednisone40 in 1 BOTTLETABLET409
71205-421-42Prednisone42 in 1 BOTTLETABLET429
71205-421-60Prednisone60 in 1 BOTTLETABLET609
71205-421-63Prednisone63 in 1 BOTTLETABLET639
71205-421-90Prednisone90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-421-10EA - Each71205-4219fe95e7c-d27a-4096-b0bd-1d41b1b03bf312020-05-08
71205-421-18EA - Each71205-4210649a933-23b9-433f-9ec9-0fb7c5d2653112020-08-06
71205-421-20EA - Each71205-421eecdf175-86c8-4357-afd5-e228e7924e0512022-03-09
71205-421-21EA - Each71205-421049e15f7-bf50-4776-8b85-90046c433d4a12021-10-08
71205-421-24EA - Each71205-421eee92ba2-7ce3-412e-a436-4b17cb8992ec12022-05-04
71205-421-28EA - Each71205-421032dab4c-46f0-4f8a-8a0b-d98f903959af12022-03-09
71205-421-30EA - Each71205-4212293e9b5-7bff-474f-a839-afb4043b0a1a12020-08-06
71205-421-63EA - Each71205-42112aa4a62-56de-417a-977e-9cec5488496d12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-421PREDNISONE TABLET [PROFICIENT RX LP]9Current NDC, Legacy NDC, 12 package rows20220919_71d70ec6-859a-4951-af98-248a864e1135.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN71d70ec6-859a-4951-af98-248a864e11359
198145prednisone 10 MG Oral TabletSCD71d70ec6-859a-4951-af98-248a864e11359

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-421-107120504211010 TABLET in 1 BOTTLE (71205-421-10) 10 tablet2020-03-100000-00-00NoNoCurrent
71205-421-187120504211818 TABLET in 1 BOTTLE (71205-421-18) 18 tablet2020-06-100000-00-00NoNoCurrent
71205-421-207120504212020 TABLET in 1 BOTTLE (71205-421-20) 20 tablet2020-03-100000-00-00NoNoCurrent
71205-421-217120504212121 TABLET in 1 BOTTLE (71205-421-21) 21 tablet2021-06-230000-00-00NoNoCurrent
71205-421-247120504212424 TABLET in 1 BOTTLE (71205-421-24) 24 tablet2022-01-190000-00-00NoNoCurrent
71205-421-287120504212828 TABLET in 1 BOTTLE (71205-421-28) 28 tablet2021-11-190000-00-00NoNoCurrent
71205-421-307120504213030 TABLET in 1 BOTTLE (71205-421-30) 30 tablet2020-03-100000-00-00NoNoCurrent
71205-421-407120504214040 TABLET in 1 BOTTLE (71205-421-40) 40 tablet2020-06-120000-00-00NoNoCurrent
71205-421-427120504214242 TABLET in 1 BOTTLE (71205-421-42) 42 tablet2020-08-250000-00-00NoNoCurrent
71205-421-607120504216060 TABLET in 1 BOTTLE (71205-421-60) 60 tablet2020-03-100000-00-00NoNoCurrent
71205-421-637120504216363 TABLET in 1 BOTTLE (71205-421-63) 63 tablet2022-09-140000-00-00NoNoCurrent
71205-421-907120504219090 TABLET in 1 BOTTLE (71205-421-90) 90 tablet2020-03-100000-00-00NoNoCurrent