P- PACK PREDNISONE 20MG, 7- DAY TAPERING DOSE PACK

Manufacturer: INTERSTELLAR PHARMACEUTICALS INC.
Effective date: 2025-02-11
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 21:25:39

Label at a glance#

ProductP- PACK PREDNISONE 20MG, 7- DAY TAPERING DOSE PACK

Active ingredientPREDNISONE

Label structure2 sections

Label contents#

Full prescribing information#

PATIENT MEDICATION INFORMATION SECTION

P-PACK Prednisone 20mg

Take 4 tabs together on day 1
Take 3 tabs together on day 2
Take 2 tabs on each of days 3,4 and 5
Then, take 1 tab daily to complete the course
15 Table t s

P-Pack Pednisone

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

P-Pack Pednisone

P-Pack Prednisone

P-PACK Prednisone

SPL INDEXING DATA ELEMENTS SECTION

P-Pack Pednisone

SPL INDEXING DATA ELEMENTS SECTION

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
312615	predniSONE 20 MG Oral Tablet	PSN	2
312615	prednisone 20 MG Oral Tablet	SCD	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
PREDNISONE Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20190419

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2205d503-be51-445b-bb34-c209cc557b3c	Product name	5	20230105
9492a99d-61c8-491f-9086-1c6a7e98c040	Product name	6	20230105
205c2cdd-a63b-cbc9-6bcb-6be6001edf81	Product name	2	20170705

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85000-0012-1	P- PACK PREDNISONE 20MG, 7- DAY TAPERING DOSE PACK	15 in 1 BOTTLE	TABLET	15		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
85000-0012	P- PACK PREDNISONE 20MG, 7- DAY TAPERING DOSE PACK (DR ADAM AU) TABLET [INTERSTELLAR PHARMACEUTICALS INC.]	2	1 package rows	20250213_2de07baf-1add-f3d1-e063-6394a90a41d8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60219-1708-1	EA - Each	60219-1708	eed53ad5-d7ba-4d21-9943-bcaf1e402a42	1	2021-11-09
60219-1708-5	EA - Each	60219-1708	7163f63c-2e26-4419-9dc0-aeed85a54c74	1	2021-11-09

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

P- PACK PREDNISONE 20MG, 7- DAY TAPERING DOSE PACK
Dr Adam Au
LACTOSE MONOHYDRATE
SILICON DIOXIDE
PREDNISONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
85000-0012	85000-0012-1
60219-1708

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
PREDNISONE	VB0R961HZT	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213386-001	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	AB		2020-06-24
A213386-002	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB		2020-06-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A213386-001	AB
A213386-002	AB

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 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A213386-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A213386-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A213386-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213386-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213386-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213386-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213386-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213386-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213386-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213386-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213386-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213386-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213386-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213386-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213386-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213386-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213386-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213386-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213386-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213386-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213386-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213386-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213386-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213386-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213386-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213386-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213386-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213386-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213386-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213386-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213386-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213386-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213386-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213386-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213386-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213386-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213386-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213386-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213386-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213386-002	AB	1	`4b0b4de00fa7…`

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
prednisone	PREDNISONE	Amneal Pharmaceuticals NY LLC	03228706-92b9-43c9-8d73-c73aa124c58d	2026-06-30	Warnings, Adverse reactions	Exact identifier ndc (product): 60219-1708
2de0704b-7601-164d-e063-6294a90a97cf			2de07baf-1add-f3d1-e063-6394a90a41d8	2025-02-11		Exact identifier spl id: 2de0704b-7601-164d-e063-6294a90a97cf spl set id: 2de07baf-1add-f3d1-e063-6394a90a41d8

Reported adverse events (FAERS/openFDA)#

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