Pravastatin Sodium

Product NDC: 70518-2887
11-digit product format: 705182887
Labeler code: 70518
Product ID: 70518-2887_4ab8510c-0de1-0008-e063-6394a90ab878
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pravastatin Sodium
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA076056
Marketing category: ANDA
Marketing start: 2020-09-15
Marketing end: 2026-08-31
Substance: PRAVASTATIN SODIUM
Active strength: 20 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-2887	70518-2887-0	D	Discontinued by firm		2026-08-03
excluded package	package	70518-2887	70518-2887-2	D	Discontinued by firm		2026-08-03

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 1 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-2887	70518-2887-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-2887	70518-2887-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-2887	70518-2887-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-2887	70518-2887-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-2887	70518-2887-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-2887	70518-2887-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-2887	70518-2887-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-2887	70518-2887-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-2887	70518-2887-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-2887	70518-2887-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-2887	70518-2887-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-2887	70518-2887-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A076056-001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24
A076056-002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24
A076056-003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076056-001	AB
A076056-002	AB
A076056-003	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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076056-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076056-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076056-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076056-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076056-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076056-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076056-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076056-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076056-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076056-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076056-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076056-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076056-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076056-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076056-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076056-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076056-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076056-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076056-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076056-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076056-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076056-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076056-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076056-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076056-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076056-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076056-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076056-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076056-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076056-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076056-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076056-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076056-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076056-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076056-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076056-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076056-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076056-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076056-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076056-001	AB	1	`8072bd15b7f6…`

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 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pravastatin Sodium	PRAVASTATIN SODIUM	REMEDYREPACK INC.	0c4b59f1-92a8-44f8-8b4c-691f35777460	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056 ndc (product): 70518-2887
Pravastatin Sodium	PRAVASTATIN SODIUM	Cardinal Health 107, LLC	ca779f66-4b9d-41da-ad0e-e4f58db9fbac	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin sodium	PRAVASTATIN SODIUM	Safecor Health LLC	0ae196a4-be3d-4cd8-9ff2-68aeb91b8678	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	b7f8c679-a602-4268-81b6-962a136a4e43	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	8df47d82-5b09-414d-99f1-7ac4c77f7c01	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin Sodium	PRAVASTATIN SODIUM	Northwind Health Company, LLC	f6ddb6c0-d0b4-2297-e053-6294a90a83c9	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin sodium	PRAVASTATIN SODIUM	Northwind Health Company, LLC	471b4dac-057d-740c-e063-6294a90af9e9	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin sodium	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	f92e12bc-40c3-4afa-9190-2f4de11ec6b3	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin sodium	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	e6a3d99c-c9cc-49d9-b0f9-503770307b70	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin sodium	PRAVASTATIN SODIUM	NuCare Pharmaceuticals, Inc.	3ef390a6-e0a0-331d-e063-6394a90a83d0	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin sodium	PRAVASTATIN SODIUM	REMEDYREPACK INC.	fa152ce7-6c07-4aaf-9374-932ce81d0cf9	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin sodium	PRAVASTATIN SODIUM	REMEDYREPACK INC.	6cef5e92-26b7-435c-878f-72a05a624560	2025-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin Sodium	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	7abc1825-182d-40bc-9f7f-968e197b4246	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin Sodium	PRAVASTATIN SODIUM	Mylan Institutional Inc.	1b00f510-c86d-46f6-b427-311a8fd14955	2025-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin sodium	PRAVASTATIN SODIUM	Aurobindo Pharma Limited	cf6f7031-33b9-40d3-bc87-32f1b6af98f2	2025-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin Sodium	PRAVASTATIN SODIUM	NuCare Pharmaceuticals, Inc.	2d40e473-f79a-e50e-e063-6294a90a4d9e	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	55f8cf43-bf8b-4729-9e5a-32fcc9696e02	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin Sodium	PRAVASTATIN SODIUM	Teva Pharmaceuticals USA, Inc.	99e0e848-f8f3-4b42-b880-8fbc42633948	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	4f9ada33-5592-4780-926d-1af49a8e064e	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056
Pravastatin Sodium	PRAVASTATIN SODIUM	Proficient Rx LP	466e2d1a-a6d6-40f8-a9f6-3e7494a34ca6	2023-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076056 application number: ANDA076056

Additional Listing Data#

Finished product: Yes
Brand name base: Pravastatin Sodium

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRAVASTATIN SODIUM	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3M8608UQ61	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
904467	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
0c4b59f1-92a8-44f8-8b4c-691f35777460	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
36361c23-a766-1581-d616-2080c781a50c	Product name	5	20190314

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2887-0	2022-02-08	C162847	48780-1	d6a99b39-46f1-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
70518-2887-0	2022-01-28	C162847	48780-1	d6a99b39-46f1-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-2887-0	Pravastatin Sodium	90 in 1 BOTTLE, PLASTIC	TABLET	90	10
70518-2887-1	Pravastatin Sodium	90 in 1 BOTTLE, PLASTIC	TABLET	90	10
70518-2887-2	Pravastatin Sodium	30 in 1 BLISTER PACK	TABLET	30	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-2887	PRAVASTATIN SODIUM TABLET [REMEDYREPACK INC.]	8	Current NDC, Legacy NDC, 3 package rows	20250406_0c4b59f1-92a8-44f8-8b4c-691f35777460.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3M8608UQ61	PRAVASTATIN SODIUM	81131-70-6	PRAVASTATIN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
904467	pravastatin sodium 20 MG Oral Tablet	PSN	0c4b59f1-92a8-44f8-8b4c-691f35777460	10
904467	pravastatin sodium 20 MG Oral Tablet	SCD	0c4b59f1-92a8-44f8-8b4c-691f35777460	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2887-0	70518288700	90 TABLET in 1 BOTTLE, PLASTIC (70518-2887-0)	90 tablet	2020-09-15	0000-00-00	No	No	Current
70518-2887-1	70518288701	90 TABLET in 1 BOTTLE, PLASTIC (70518-2887-1)	90 tablet	2022-09-16	2026-08-31	No	No	Current
70518-2887-2	70518288702	30 TABLET in 1 BLISTER PACK (70518-2887-2)	30 tablet	2022-11-08	0000-00-00	No	No	Current