Prednisone

Product NDC: 12634-184
11-digit product format: 126340184
Labeler code: 12634
Product ID: 12634-184_357d7013-18b1-3554-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: Apotheca Inc.
Application: ANDA080292
Marketing category: ANDA
Marketing start: 1972-05-22
Marketing end: 0000-00-00
Substance: PREDNISONE
Active strength: 5 mg/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 29 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-184		I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-00	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-01	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-09	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-40	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-42	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-50	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-52	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-54	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-57	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-59	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-60	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-61	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-63	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-66	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-67	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-69	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-71	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-74	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-78	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-79	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-80	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-81	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-82	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-85	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-91	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-94	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-95	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-184	12634-184-96	I	Inactivated by FDA	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 10 · 551 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-66	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-67	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-52	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-81	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-82	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-63	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-69	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-74	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-95	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-184-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-66	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-79	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-94	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-67	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-52	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-81	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-82	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-63	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-69	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-54	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-74	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-95	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-184-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-184-42	`2ef7874e63bc…`	`57b86245f4fa…`

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080292-001	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A080292-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080292-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080292-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080292-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080292-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080292-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080292-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080292-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080292-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080292-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080292-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080292-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080292-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080292-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080292-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080292-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080292-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080292-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080292-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080292-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080292-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080292-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080292-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080292-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080292-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080292-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080292-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080292-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080292-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080292-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080292-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080292-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080292-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080292-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080292-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080292-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080292-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080292-001	AB	1	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
12634-184-00	Prednisone Tablets 5 mg
12634-184-01	Prednisone Tablets 5 mg
12634-184-09	Prednisone Tablets 5 mg
12634-184-40	Prednisone Tablets 5 mg
12634-184-42	Prednisone Tablets 5 mg
12634-184-50	Prednisone Tablets 5 mg
12634-184-52	Prednisone Tablets 5 mg
12634-184-54	Prednisone Tablets 5 mg
12634-184-57	Prednisone Tablets 5 mg
12634-184-59	Prednisone Tablets 5 mg
12634-184-60	Prednisone Tablets 5 mg
12634-184-61	Prednisone Tablets 5 mg
12634-184-63	Prednisone Tablets 5 mg
12634-184-66	Prednisone Tablets 5 mg
12634-184-67	Prednisone Tablets 5 mg
12634-184-69	Prednisone Tablets 5 mg
12634-184-71	Prednisone Tablets 5 mg
12634-184-74	Prednisone Tablets 5 mg
12634-184-78	Prednisone Tablets 5 mg
12634-184-79	Prednisone Tablets 5 mg
12634-184-80	Prednisone Tablets 5 mg
12634-184-81	Prednisone Tablets 5 mg
12634-184-82	Prednisone Tablets 5 mg
12634-184-85	Prednisone Tablets 5 mg
12634-184-91	Prednisone Tablets 5 mg
12634-184-94	Prednisone Tablets 5 mg
12634-184-95	Prednisone Tablets 5 mg
12634-184-96	Prednisone Tablets 5 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-184-00	Prednisone	10 in 1 BOTTLE	TABLET	10	2
12634-184-01	Prednisone	100 in 1 BOTTLE	TABLET	100	2
12634-184-09	Prednisone	35 in 1 BOTTLE	TABLET	35	2
12634-184-40	Prednisone	40 in 1 BOTTLE	TABLET	40	2
12634-184-42	Prednisone	42 in 1 BOTTLE	TABLET	42	2
12634-184-50	Prednisone	50 in 1 BOTTLE	TABLET	50	2
12634-184-52	Prednisone	12 in 1 BLISTER PACK	TABLET	12	2
12634-184-54	Prednisone	14 in 1 BOTTLE	TABLET	14	2
12634-184-57	Prednisone	20 in 1 BLISTER PACK	TABLET	20	2
12634-184-59	Prednisone	30 in 1 BOTTLE	TABLET	30	2
12634-184-60	Prednisone	60 in 1 BOTTLE	TABLET	60	2
12634-184-61	Prednisone	10 in 1 BLISTER PACK	TABLET	10	2
12634-184-63	Prednisone	3 in 1 BLISTER PACK	TABLET	3	2
12634-184-66	Prednisone	6 in 1 BLISTER PACK	TABLET	6	2
12634-184-67	Prednisone	7 in 1 BLISTER PACK	TABLET	7	2
12634-184-69	Prednisone	9 in 1 BLISTER PACK	TABLET	9	2
12634-184-71	Prednisone	30 in 1 BOTTLE	TABLET	30	2
12634-184-74	Prednisone	24 in 1 BOTTLE	TABLET	24	2
12634-184-78	Prednisone	28 in 1 BOTTLE	TABLET	28	2
12634-184-79	Prednisone	25 in 1 BOTTLE	TABLET	25	2
12634-184-80	Prednisone	20 in 1 BOTTLE	TABLET	20	2
12634-184-81	Prednisone	21 in 1 BOTTLE	TABLET	21	2
12634-184-82	Prednisone	12 in 1 BOTTLE	TABLET	12	2
12634-184-85	Prednisone	15 in 1 BOTTLE	TABLET	15	2
12634-184-91	Prednisone	1 in 1 BLISTER PACK	TABLET	1	2
12634-184-94	Prednisone	4 in 1 BOTTLE	TABLET	4	2
12634-184-95	Prednisone	5 in 1 BOTTLE	TABLET	5	2
12634-184-96	Prednisone	6 in 1 BOTTLE	TABLET	6	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-184	PREDNISONE TABLET [APOTHECA INC.]	2	Legacy NDC, 28 package rows	20160618_35427b4b-534d-6414-e054-00144ff88e88.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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Northwind Health Company, LLC	da7f948f-8039-5f0d-e053-2a95a90ad0f0	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080292 application number: ANDA080292
Prednisone	PREDNISONE	QPharma, Inc.	c0e147a8-36a9-1e61-e053-2a95a90afd62	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080292 application number: ANDA080292
Prednisone	PREDNISONE	Golden State Medical Supply, Inc.	1e05e071-0407-0970-e063-6294a90a6c65	2025-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080292 application number: ANDA080292
Prednisone	PREDNISONE	Bryant Ranch Prepack	91167f27-6f36-4b89-a530-be26209e4301	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080292 application number: ANDA080292
Prednisone	PREDNISONE	Mylan Pharmaceuticals Inc.	fec09050-5ac2-451b-a2b9-5a21b2def212	2024-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080292 application number: ANDA080292

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VB0R961HZT	PREDNISONE	53-03-2	PREDNISONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312617	predniSONE 5 MG Oral Tablet	PSN	35427b4b-534d-6414-e054-00144ff88e88	2
312617	prednisone 5 MG Oral Tablet	SCD	35427b4b-534d-6414-e054-00144ff88e88	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
12634-184-00	12634018400	10 in 1 BOTTLE	Historical
12634-184-01	12634018401	100 in 1 BOTTLE	Historical
12634-184-09	12634018409	35 in 1 BOTTLE	Historical
12634-184-40	12634018440	40 in 1 BOTTLE	Historical
12634-184-42	12634018442	42 in 1 BOTTLE	Historical
12634-184-50	12634018450	50 in 1 BOTTLE	Historical
12634-184-52	12634018452	12 in 1 BLISTER PACK	Historical
12634-184-54	12634018454	14 in 1 BOTTLE	Historical
12634-184-57	12634018457	20 in 1 BLISTER PACK	Historical
12634-184-59	12634018459	30 in 1 BOTTLE	Historical
12634-184-60	12634018460	60 in 1 BOTTLE	Historical
12634-184-61	12634018461	10 in 1 BLISTER PACK	Historical
12634-184-63	12634018463	3 in 1 BLISTER PACK	Historical
12634-184-66	12634018466	6 in 1 BLISTER PACK	Historical
12634-184-67	12634018467	7 in 1 BLISTER PACK	Historical
12634-184-69	12634018469	9 in 1 BLISTER PACK	Historical
12634-184-71	12634018471	30 in 1 BOTTLE	Historical
12634-184-74	12634018474	24 in 1 BOTTLE	Historical
12634-184-78	12634018478	28 in 1 BOTTLE	Historical
12634-184-79	12634018479	25 in 1 BOTTLE	Historical
12634-184-80	12634018480	20 in 1 BOTTLE	Historical
12634-184-81	12634018481	21 in 1 BOTTLE	Historical
12634-184-82	12634018482	12 in 1 BOTTLE	Historical
12634-184-85	12634018485	15 in 1 BOTTLE	Historical
12634-184-91	12634018491	1 in 1 BLISTER PACK	Historical
12634-184-94	12634018494	4 in 1 BOTTLE	Historical
12634-184-95	12634018495	5 in 1 BOTTLE	Historical
12634-184-96	12634018496	6 in 1 BOTTLE	Historical