Prednisone

Product NDC: 12634-188
11-digit product format: 126340188
Labeler code: 12634
Product ID: 12634-188_280c9fe8-339a-177a-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prednisone
Dosage form: TABLET
Route: ORAL
Labeler: Apotheca Inc.
Application: ANDA083677
Marketing category: ANDA
Marketing start: 1974-02-26
Marketing end: 0000-00-00
Substance: PREDNISONE
Active strength: 20 mg/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 15 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-188		I	Inactivated by FDA	2026-08-17
excluded package	package	12634-188	12634-188-00	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-188	12634-188-01	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-188	12634-188-52	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-188	12634-188-54	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-188	12634-188-55	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-188	12634-188-57	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-188	12634-188-71	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-188	12634-188-79	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-188	12634-188-80	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-188	12634-188-81	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-188	12634-188-82	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-188	12634-188-84	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-188	12634-188-85	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-188	12634-188-91	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 6 · 315 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	12634-188-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-188-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-188-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-188-81	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-188-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-188-82	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-188-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-188-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-188-52	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-188-84	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-188-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-188-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-188-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-188-55	`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	12634-188-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-188-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-188-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-188-81	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-188-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-188-82	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-188-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-188-54	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-188-52	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-188-84	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-188-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-188-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-188-79	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-188-55	`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	12634-188-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-188-71	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-188-85	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-188-81	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-188-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-188-82	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-188-57	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-188-54	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-188-52	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-188-84	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-188-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-188-91	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-188-79	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-188-55	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-188-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-188-71	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-188-85	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-188-81	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-188-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-188-82	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-188-57	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-188-54	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-188-52	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-188-84	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-188-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-188-91	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-188-79	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-188-55	`a1b67e2a42f9…`	`c4cf2c586c0d…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A083677-001	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982
A083677-002	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982
A083677-003	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	AB		1985-12-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A083677-001	AB
A083677-002	AB
A083677-003	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 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083677-002	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083677-003	PREDNISONE	10MG	TABLET / ORAL	AB		1985-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083677-002	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083677-003	PREDNISONE	10MG	TABLET / ORAL	AB		1985-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083677-002	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083677-003	PREDNISONE	10MG	TABLET / ORAL	AB		1985-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A083677-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083677-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083677-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083677-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083677-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083677-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083677-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083677-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083677-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083677-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083677-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083677-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083677-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083677-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083677-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083677-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083677-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083677-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083677-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083677-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083677-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083677-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083677-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083677-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083677-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083677-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083677-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083677-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083677-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083677-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083677-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083677-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083677-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083677-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083677-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083677-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083677-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083677-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083677-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083677-001	AB	1	`a67488948f0b…`

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
12634-188-00	Prednisone Tablets - WW
12634-188-01	Prednisone Tablets - WW
12634-188-52	Prednisone Tablets - WW
12634-188-54	Prednisone Tablets - WW
12634-188-55	Prednisone Tablets - WW
12634-188-57	Prednisone Tablets - WW
12634-188-71	Prednisone Tablets - WW
12634-188-79	Prednisone Tablets - WW
12634-188-80	Prednisone Tablets - WW
12634-188-81	Prednisone Tablets - WW
12634-188-82	Prednisone Tablets - WW
12634-188-84	Prednisone Tablets - WW
12634-188-85	Prednisone Tablets - WW
12634-188-91	Prednisone Tablets - WW

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-188-00	Prednisone	10 in 1 BOTTLE	TABLET	10	1
12634-188-01	Prednisone	100 in 1 BOTTLE	TABLET	100	1
12634-188-52	Prednisone	12 in 1 BLISTER PACK	TABLET	12	1
12634-188-54	Prednisone	14 in 1 BLISTER PACK	TABLET	14	1
12634-188-55	Prednisone	15 in 1 BLISTER PACK	TABLET	15	1
12634-188-57	Prednisone	20 in 1 BLISTER PACK	TABLET	20	1
12634-188-71	Prednisone	30 in 1 BOTTLE	TABLET	30	1
12634-188-79	Prednisone	25 in 1 BOTTLE	TABLET	25	1
12634-188-80	Prednisone	20 in 1 BOTTLE	TABLET	20	1
12634-188-81	Prednisone	21 in 1 BOTTLE	TABLET	21	1
12634-188-82	Prednisone	12 in 1 BOTTLE	TABLET	12	1
12634-188-84	Prednisone	14 in 1 BOTTLE	TABLET	14	1
12634-188-85	Prednisone	15 in 1 BOTTLE	TABLET	15	1
12634-188-91	Prednisone	1 in 1 BLISTER PACK	TABLET	1	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-188	PREDNISONE TABLET [APOTHECA INC.]	1	Legacy NDC, 14 package rows	20151229_280c9fe8-3399-177a-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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Golden State Medical Supply, Inc.	1e05e071-0407-0970-e063-6294a90a6c65	2025-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083677 application number: ANDA083677
Prednisone	PREDNISONE	Mylan Pharmaceuticals Inc.	fec09050-5ac2-451b-a2b9-5a21b2def212	2024-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083677 application number: ANDA083677

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
312615	predniSONE 20 MG Oral Tablet	PSN	280c9fe8-3399-177a-e054-00144ff88e88	1
312615	prednisone 20 MG Oral Tablet	SCD	280c9fe8-3399-177a-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
12634-188-00	12634018800	10 in 1 BOTTLE	Historical
12634-188-01	12634018801	100 in 1 BOTTLE	Historical
12634-188-52	12634018852	12 in 1 BLISTER PACK	Historical
12634-188-54	12634018854	14 in 1 BLISTER PACK	Historical
12634-188-55	12634018855	15 in 1 BLISTER PACK	Historical
12634-188-57	12634018857	20 in 1 BLISTER PACK	Historical
12634-188-71	12634018871	30 in 1 BOTTLE	Historical
12634-188-79	12634018879	25 in 1 BOTTLE	Historical
12634-188-80	12634018880	20 in 1 BOTTLE	Historical
12634-188-81	12634018881	21 in 1 BOTTLE	Historical
12634-188-82	12634018882	12 in 1 BOTTLE	Historical
12634-188-84	12634018884	14 in 1 BOTTLE	Historical
12634-188-85	12634018885	15 in 1 BOTTLE	Historical
12634-188-91	12634018891	1 in 1 BLISTER PACK	Historical