Pravastatin Sodium

Product NDC: 51079-782
11-digit product format: 510790782
Labeler code: 51079
Product ID: 51079-782_311a7c70-966e-2400-e063-6394a90aae6a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pravastatin Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Institutional Inc.
Application: ANDA076056
Marketing category: ANDA
Marketing start: 2007-10-03
Marketing end: 2026-08-31
Substance: PRAVASTATIN SODIUM
Active strength: 40 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Pravastatin Sodium

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRAVASTATIN SODIUM	40 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
904467	Internal RxNorm lookup
904475	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
1b00f510-c86d-46f6-b427-311a8fd14955	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51079-782-01	Pravastatin Sodium	1 in 1 BLISTER PACK	TABLET	1		14
51079-782-20	Pravastatin Sodium	100 in 1 CARTON	TABLET	100		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51079-782-01	EA - Each	51079-782	cde33c60-30b6-40ea-8e47-88f5e2a3b9c8	1	2012-07-24
51079-782-20	EA - Each	51079-782	bf50d2f1-7ee3-4740-84c2-d44e32b4fbfb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRAVASTATIN SODIUM	ACTIVE INGREDIENT	3M8608UQ61	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
PRAVASTATIN	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	4
PRAVASTATIN SODIUM	ACTIVE INGREDIENT	3M8608UQ61	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3
PRAVASTATIN	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51079-782	PRAVASTATIN SODIUM TABLET [MYLAN INSTITUTIONAL INC.]	14	Current NDC, Legacy NDC, 2 package rows	20250326_1b00f510-c86d-46f6-b427-311a8fd14955.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 · 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
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 ndc (product): 51079-782
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

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	ca779f66-4b9d-41da-ad0e-e4f58db9fbac	15
904475	pravastatin sodium 40 MG Oral Tablet	PSN	ca779f66-4b9d-41da-ad0e-e4f58db9fbac	15
904467	pravastatin sodium 20 MG Oral Tablet	SCD	ca779f66-4b9d-41da-ad0e-e4f58db9fbac	15
904475	pravastatin sodium 40 MG Oral Tablet	SCD	ca779f66-4b9d-41da-ad0e-e4f58db9fbac	15
904467	pravastatin sodium 20 MG Oral Tablet	PSN	1b00f510-c86d-46f6-b427-311a8fd14955	14
904475	pravastatin sodium 40 MG Oral Tablet	PSN	1b00f510-c86d-46f6-b427-311a8fd14955	14
904467	pravastatin sodium 20 MG Oral Tablet	SCD	1b00f510-c86d-46f6-b427-311a8fd14955	14
904475	pravastatin sodium 40 MG Oral Tablet	SCD	1b00f510-c86d-46f6-b427-311a8fd14955	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51079-782-01	51079078201	1 in 1 BLISTER PACK						Historical
51079-782-20	51079078220	100 BLISTER PACK in 1 CARTON (51079-782-20) / 1 TABLET in 1 BLISTER PACK (51079-782-01)	100 blister pack	2007-10-03	2026-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pravastatin Sodium	Cardinal Health 107, LLC	2026-07-10	HUMAN PRESCRIPTION DRUG LABEL	16
Pravastatin Sodium	Mylan Institutional Inc.	2025-03-24	HUMAN PRESCRIPTION DRUG LABEL	14