PREDNISONE

Product NDC
68071-3721
11-digit product format
680713721
Labeler code
68071
Product ID
68071-3721_4bd21794-fa93-aa02-e063-6294a90a9471
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA215672
Marketing category
ANDA
Marketing start
2022-03-28
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215672-001PREDNISONEPREDNISONE2.5MGTABLET / ORALAB2022-03-28
A215672-002PREDNISONEPREDNISONE5MGTABLET / ORALAB2022-03-28
A215672-003PREDNISONEPREDNISONE10MGTABLET / ORALAB2022-03-28
A215672-004PREDNISONEPREDNISONE20MGTABLET / ORALAB2022-03-28
A215672-005PREDNISONEPREDNISONE50MGTABLET / ORALAB2022-03-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A215672-001AB
A215672-002AB
A215672-003AB
A215672-004AB
A215672-005AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A215672-001PREDNISONE2.5MGTABLET / ORALAB2022-03-2884e616aacf4f…
2026-09-14 22:38:342026-08A215672-002PREDNISONE5MGTABLET / ORALAB2022-03-2884e616aacf4f…
2026-09-14 22:38:342026-08A215672-003PREDNISONE10MGTABLET / ORALAB2022-03-2884e616aacf4f…
2026-09-14 22:38:342026-08A215672-004PREDNISONE20MGTABLET / ORALAB2022-03-2884e616aacf4f…
2026-09-14 22:38:342026-08A215672-005PREDNISONE50MGTABLET / ORALAB2022-03-2884e616aacf4f…
2026-08-18 06:07:402026-07A215672-001PREDNISONE2.5MGTABLET / ORALAB2022-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07A215672-002PREDNISONE5MGTABLET / ORALAB2022-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07A215672-003PREDNISONE10MGTABLET / ORALAB2022-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07A215672-004PREDNISONE20MGTABLET / ORALAB2022-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07A215672-005PREDNISONE50MGTABLET / ORALAB2022-03-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215672-001PREDNISONE2.5MGTABLET / ORALAB2022-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215672-002PREDNISONE5MGTABLET / ORALAB2022-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215672-003PREDNISONE10MGTABLET / ORALAB2022-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215672-004PREDNISONE20MGTABLET / ORALAB2022-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215672-005PREDNISONE50MGTABLET / ORALAB2022-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215672-001PREDNISONE2.5MGTABLET / ORALAB2022-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215672-002PREDNISONE5MGTABLET / ORALAB2022-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215672-003PREDNISONE10MGTABLET / ORALAB2022-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215672-004PREDNISONE20MGTABLET / ORALAB2022-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215672-005PREDNISONE50MGTABLET / ORALAB2022-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A215672-001PREDNISONE2.5MGTABLET / ORALAB2022-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215672-002PREDNISONE5MGTABLET / ORALAB2022-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215672-003PREDNISONE10MGTABLET / ORALAB2022-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215672-004PREDNISONE20MGTABLET / ORALAB2022-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215672-005PREDNISONE50MGTABLET / ORALAB2022-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215672-001PREDNISONE2.5MGTABLET / ORALAB2022-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215672-002PREDNISONE5MGTABLET / ORALAB2022-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215672-003PREDNISONE10MGTABLET / ORALAB2022-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215672-004PREDNISONE20MGTABLET / ORALAB2022-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215672-005PREDNISONE50MGTABLET / ORALAB2022-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215672-001PREDNISONE2.5MGTABLET / ORALAB2022-03-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215672-002PREDNISONE5MGTABLET / ORALAB2022-03-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215672-003PREDNISONE10MGTABLET / ORALAB2022-03-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215672-004PREDNISONE20MGTABLET / ORALAB2022-03-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215672-005PREDNISONE50MGTABLET / ORALAB2022-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215672-001PREDNISONE2.5MGTABLET / ORALAB2022-03-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215672-002PREDNISONE5MGTABLET / ORALAB2022-03-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215672-003PREDNISONE10MGTABLET / ORALAB2022-03-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215672-004PREDNISONE20MGTABLET / ORALAB2022-03-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215672-005PREDNISONE50MGTABLET / ORALAB2022-03-2803ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A215672-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A215672-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A215672-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A215672-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A215672-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A215672-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215672-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215672-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215672-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A215672-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215672-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215672-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215672-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215672-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215672-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215672-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215672-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215672-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215672-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215672-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215672-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215672-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215672-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215672-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215672-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215672-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215672-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215672-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215672-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215672-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215672-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215672-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215672-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215672-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215672-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215672-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215672-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215672-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215672-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215672-005AB103ed91905a0d…

Reported adverse events (FAERS/openFDA)#

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

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VB0R961HZTInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312615Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2760a808-b076-5887-e063-6294a90a79aeAvailable on FDA.report

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
68071-3721-0PREDNISONE10 in 1 BOTTLETABLET109
68071-3721-1PREDNISONE18 in 1 BOTTLETABLET189
68071-3721-2PREDNISONE20 in 1 BOTTLETABLET209
68071-3721-3PREDNISONE30 in 1 BOTTLETABLET309
68071-3721-4PREDNISONE14 in 1 BOTTLETABLET149
68071-3721-5PREDNISONE15 in 1 BOTTLETABLET159
68071-3721-7PREDNISONE21 in 1 BOTTLETABLET219
68071-3721-8PREDNISONE8 in 1 BOTTLETABLET89

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3721PREDNISONE TABLET [NUCARE PHARMACEUTICALS, INC.]7Current NDC, 8 package rows20250305_2760a808-b076-5887-e063-6294a90a79ae.zip

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 1 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREDNISONEPREDNISONEREMEDYREPACK INC.0993b354-d936-472b-bafc-114f0f81bfb02026-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215672
application number: ANDA215672
PREDNISONEPREDNISONEProficient Rx LPeabbefb2-21a9-4745-8021-1aac1ece7f9d2026-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215672
application number: ANDA215672
PREDNISONEPREDNISONENuCare Pharmaceuticals,Inc.288ecb6d-3b0b-db95-e063-6394a90a78ff2026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215672
application number: ANDA215672
PREDNISONEPREDNISONEST. MARY'S MEDICAL PARK PHARMACY42e0decc-4d11-e7e6-e063-6394a90a9fcc2026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215672
application number: ANDA215672
PREDNISONEPREDNISONECoupler LLC50734a48-807d-cc00-e063-6294a90a4dae2026-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215672
application number: ANDA215672
PREDNISONEPREDNISONEA-S Medication Solutions53c66f70-58fd-4d4c-b054-e5cefdc0c6372026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215672
application number: ANDA215672
PREDNISONEPREDNISONEA-S Medication Solutionse753e2bc-acca-46eb-888c-ae72fcac6ca42026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215672
application number: ANDA215672
PREDNISONEPREDNISONEA-S Medication Solutionsa8f6298a-1084-4226-bfd9-a543a26ad2e72026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215672
application number: ANDA215672
PREDNISONEPREDNISONENuCare Pharmaceuticals, Inc.2760a808-b076-5887-e063-6294a90a79ae2026-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215672
application number: ANDA215672
ndc (product): 68071-3721
PREDNISONEPREDNISONEQPharma, Inc.4aa286e3-e272-8095-e063-6394a90ae8712026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215672
application number: ANDA215672
PREDNISONEPREDNISONEASCLEMED USA INC.bf6ebe58-e7bb-49d3-842e-3372f8ba61722026-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215672
application number: ANDA215672
PREDNISONEPREDNISONENuCare Pharmaceuticals, Inc.292e2529-711c-7b74-e063-6394a90a660d2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215672
application number: ANDA215672
PREDNISONEPREDNISONEREMEDYREPACK INC.ab9bffed-b1a2-4e82-ac45-bee40b41060f2026-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215672
application number: ANDA215672
PREDNISONEPREDNISONEA-S Medication Solutions35de14e3-d748-46bd-a307-6a1a27c626a22025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215672
application number: ANDA215672
PREDNISONEPREDNISONERedpharm Drug44f5e966-5a12-e2ff-e063-6294a90a919e2025-12-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215672
application number: ANDA215672
PREDNISONEPREDNISONECoupler LLC41e6f1c3-d225-0ff0-e063-6394a90ace882025-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215672
application number: ANDA215672
PREDNISONEPREDNISONEPD-Rx Pharmaceuticals, Inc.c21be016-6b25-4e09-b253-23b58884ccb62025-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215672
application number: ANDA215672
PREDNISONEPREDNISONEPreferred Pharmaceuticals Inc.28130e6d-7cda-459a-9f80-cacaa82d71d32025-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215672
application number: ANDA215672
PREDNISONEPREDNISONENuCare Pharmaceuticals,Inc.27d8dcad-a024-ed85-e063-6394a90a420d2025-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215672
application number: ANDA215672
PREDNISONEPREDNISONEPreferred Pharmaceuticals Inc.60bb6698-d1fc-4720-9954-266a3d650f0d2025-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215672
application number: ANDA215672

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN2760a808-b076-5887-e063-6294a90a79ae9
312615prednisone 20 MG Oral TabletSCD2760a808-b076-5887-e063-6294a90a79ae9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3721-06807137210010 TABLET in 1 BOTTLE (68071-3721-0) 10 tablet2024-12-04NoNoCurrent
68071-3721-16807137210118 TABLET in 1 BOTTLE (68071-3721-1) 18 tablet2024-12-19NoNoCurrent
68071-3721-26807137210220 TABLET in 1 BOTTLE (68071-3721-2) 20 tablet2024-11-20NoNoCurrent
68071-3721-36807137210330 TABLET in 1 BOTTLE (68071-3721-3) 30 tablet2025-03-03NoNoCurrent
68071-3721-46807137210414 TABLET in 1 BOTTLE (68071-3721-4) 14 tablet2026-02-27NoNoCurrent
68071-3721-56807137210515 TABLET in 1 BOTTLE (68071-3721-5) 15 tablet2024-12-02NoNoCurrent
68071-3721-76807137210721 TABLET in 1 BOTTLE (68071-3721-7) 21 tablet2025-03-03NoNoCurrent
68071-3721-8680713721088 TABLET in 1 BOTTLE (68071-3721-8) 8 tablet2024-12-10NoNoCurrent