PRAVASTATIN SODIUM

Product NDC: 60505-1323
11-digit product format: 605051323
Labeler code: 60505
Product ID: 60505-1323_4ee96b96-8019-3bb3-6737-f6f88c6289d9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PRAVASTATIN SODIUM
Dosage form: TABLET
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA076341
Marketing category: ANDA
Marketing start: 2011-07-18
Substance: PRAVASTATIN SODIUM
Active strength: 80 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076341-001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23
A076341-002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23
A076341-003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23
A076341-004	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A076341-001	AB
A076341-002	AB
A076341-003	AB
A076341-004	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 5 · 164 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	A076341-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076341-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076341-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076341-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076341-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076341-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076341-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076341-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076341-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076341-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076341-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076341-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076341-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076341-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076341-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076341-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076341-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076341-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076341-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076341-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076341-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076341-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076341-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076341-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076341-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076341-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076341-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076341-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076341-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076341-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076341-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076341-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076341-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076341-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076341-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076341-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076341-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076341-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076341-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076341-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A076341-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076341-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076341-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076341-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076341-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076341-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076341-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076341-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076341-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076341-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076341-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076341-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076341-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076341-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076341-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076341-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076341-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076341-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076341-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076341-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076341-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076341-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076341-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076341-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076341-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076341-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076341-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076341-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076341-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076341-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076341-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076341-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076341-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076341-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076341-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076341-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076341-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076341-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076341-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076341-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: PRAVASTATIN SODIUM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRAVASTATIN SODIUM	80 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
904458	Internal RxNorm lookup
904467	Internal RxNorm lookup
904475	Internal RxNorm lookup
904481	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
dcf45e4f-b46e-6fbb-b67a-2ff619ab1780	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	SPL version
60505-1323-1	PRAVASTATIN SODIUM	100 in 1 BOTTLE	TABLET	100	18
60505-1323-5	PRAVASTATIN SODIUM	500 in 1 BOTTLE	TABLET	500	18
60505-1323-7	PRAVASTATIN SODIUM	1000 in 1 BOTTLE	TABLET	1000	18
60505-1323-8	PRAVASTATIN SODIUM	5000 in 1 BOTTLE	TABLET	5000	18
60505-1323-9	PRAVASTATIN SODIUM	90 in 1 BOTTLE	TABLET	90	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-1323-5	EA - Each	60505-1323	a7fe643d-d6c9-4bd9-b52d-78458044b90d	1	2012-07-24
60505-1323-9	EA - Each	60505-1323	60cf2245-2f14-4bf4-b74e-861a31330858	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 [APOTEX CORP.]	6
PRAVASTATIN	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM TABLET [APOTEX CORP.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM TABLET [APOTEX CORP.]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PRAVASTATIN SODIUM TABLET [APOTEX CORP.]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PRAVASTATIN SODIUM TABLET [APOTEX CORP.]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PRAVASTATIN SODIUM TABLET [APOTEX CORP.]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PRAVASTATIN SODIUM TABLET [APOTEX CORP.]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PRAVASTATIN SODIUM TABLET [APOTEX CORP.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRAVASTATIN SODIUM TABLET [APOTEX CORP.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-1323	PRAVASTATIN SODIUM TABLET [APOTEX CORP.]	16	Current NDC, Legacy NDC, 5 package rows	20241211_dcf45e4f-b46e-6fbb-b67a-2ff619ab1780.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 3 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Quallent	e9c188f7-cd6f-afac-b493-36552d86589e	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Apotex Corp.	dcf45e4f-b46e-6fbb-b67a-2ff619ab1780	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341 ndc (product): 60505-1323
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	REMEDYREPACK INC.	e4dbaa72-7b3e-4aef-983b-90efb2b343cd	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	c5f611aa-9974-422e-a353-5d834a33937c	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	8dbdc80d-9d8c-4e22-9108-d87a77e07a6b	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	REMEDYREPACK INC.	5ecd9fd1-7662-412d-99c5-13c77188748c	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	REMEDYREPACK INC.	76e5fdf8-bd03-4cd5-9361-e61678cb3de9	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Cardinal Health 107, LLC	3e218ad6-5b47-4cca-81be-ebaea5795964	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Cardinal Health 107, LLC	9289f9ed-b6e3-4e81-bdb8-6aedbd5288a9	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	14390bfa-3bcb-43e1-936c-1977cb37427d	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	8d1bf7a5-bf11-47e3-afca-dcc13f2d3068	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Northwind Health Company, LLC	4fad5d73-aa79-58f2-e063-6294a90af4aa	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	93b0e546-9e0f-40d1-9b1e-082bf16400a4	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	d69e8af8-dbd4-43d9-8e9a-4aed3923a17c	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	f4b330ce-dfb0-4e4e-9f37-482458820c66	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Major Pharmaceuticals	1d5bce9c-a788-4c52-a69e-c53174b8d061	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	64ccb4b5-b77e-4b23-8c74-4685287edb4b	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	c0b1b483-1a19-4966-89b1-118ec660f203	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	AvPAK	ba4ac602-46fa-8386-e053-2995a90a9764	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	3e6d1c1e-d5f7-42ec-bcdd-8fc310acdf21	2026-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341

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
904481	pravastatin sodium 80 MG Oral Tablet	PSN	97123f09-b5ad-45c2-8bb7-f50566b56b08	106
904481	pravastatin sodium 80 MG Oral Tablet	SCD	97123f09-b5ad-45c2-8bb7-f50566b56b08	106
904481	pravastatin sodium 80 MG Oral Tablet	PSN	c0b1b483-1a19-4966-89b1-118ec660f203	104
904481	pravastatin sodium 80 MG Oral Tablet	SCD	c0b1b483-1a19-4966-89b1-118ec660f203	104
904481	pravastatin sodium 80 MG Oral Tablet	PSN	7b4ef7a8-47e5-428f-91de-7307dcbb9167	29
904481	pravastatin sodium 80 MG Oral Tablet	SCD	7b4ef7a8-47e5-428f-91de-7307dcbb9167	29
904458	pravastatin sodium 10 MG Oral Tablet	PSN	dcf45e4f-b46e-6fbb-b67a-2ff619ab1780	18
904467	pravastatin sodium 20 MG Oral Tablet	PSN	dcf45e4f-b46e-6fbb-b67a-2ff619ab1780	18
904475	pravastatin sodium 40 MG Oral Tablet	PSN	dcf45e4f-b46e-6fbb-b67a-2ff619ab1780	18
904481	pravastatin sodium 80 MG Oral Tablet	PSN	dcf45e4f-b46e-6fbb-b67a-2ff619ab1780	18
904458	pravastatin sodium 10 MG Oral Tablet	SCD	dcf45e4f-b46e-6fbb-b67a-2ff619ab1780	18
904467	pravastatin sodium 20 MG Oral Tablet	SCD	dcf45e4f-b46e-6fbb-b67a-2ff619ab1780	18
904475	pravastatin sodium 40 MG Oral Tablet	SCD	dcf45e4f-b46e-6fbb-b67a-2ff619ab1780	18
904481	pravastatin sodium 80 MG Oral Tablet	SCD	dcf45e4f-b46e-6fbb-b67a-2ff619ab1780	18
904481	pravastatin sodium 80 MG Oral Tablet	PSN	abcfc343-7ac9-4fce-b368-fd05cf14b0e2	13
904481	pravastatin sodium 80 MG Oral Tablet	SCD	abcfc343-7ac9-4fce-b368-fd05cf14b0e2	13
904458	pravastatin sodium 10 MG Oral Tablet	PSN	ba4ac602-46fa-8386-e053-2995a90a9764	6
904467	pravastatin sodium 20 MG Oral Tablet	PSN	ba4ac602-46fa-8386-e053-2995a90a9764	6
904475	pravastatin sodium 40 MG Oral Tablet	PSN	ba4ac602-46fa-8386-e053-2995a90a9764	6
904481	pravastatin sodium 80 MG Oral Tablet	PSN	ba4ac602-46fa-8386-e053-2995a90a9764	6
904458	pravastatin sodium 10 MG Oral Tablet	SCD	ba4ac602-46fa-8386-e053-2995a90a9764	6
904467	pravastatin sodium 20 MG Oral Tablet	SCD	ba4ac602-46fa-8386-e053-2995a90a9764	6
904475	pravastatin sodium 40 MG Oral Tablet	SCD	ba4ac602-46fa-8386-e053-2995a90a9764	6
904481	pravastatin sodium 80 MG Oral Tablet	SCD	ba4ac602-46fa-8386-e053-2995a90a9764	6
904458	pravastatin sodium 10 MG Oral Tablet	PSN	97178675-3691-2d93-e053-2995a90aa5c1	5
904467	pravastatin sodium 20 MG Oral Tablet	PSN	97178675-3691-2d93-e053-2995a90aa5c1	5
904475	pravastatin sodium 40 MG Oral Tablet	PSN	97178675-3691-2d93-e053-2995a90aa5c1	5
904481	pravastatin sodium 80 MG Oral Tablet	PSN	97178675-3691-2d93-e053-2995a90aa5c1	5
904458	pravastatin sodium 10 MG Oral Tablet	SCD	97178675-3691-2d93-e053-2995a90aa5c1	5
904467	pravastatin sodium 20 MG Oral Tablet	SCD	97178675-3691-2d93-e053-2995a90aa5c1	5
904475	pravastatin sodium 40 MG Oral Tablet	SCD	97178675-3691-2d93-e053-2995a90aa5c1	5
904481	pravastatin sodium 80 MG Oral Tablet	SCD	97178675-3691-2d93-e053-2995a90aa5c1	5
904481	pravastatin sodium 80 MG Oral Tablet	PSN	ebd794ba-90c3-4d81-9c45-4aa9d9454359	4
904481	pravastatin sodium 80 MG Oral Tablet	PSN	df75b04e-3e85-9705-e053-2995a90af83f	4
904481	pravastatin sodium 80 MG Oral Tablet	SCD	df75b04e-3e85-9705-e053-2995a90af83f	4
904481	pravastatin sodium 80 MG Oral Tablet	SCD	ebd794ba-90c3-4d81-9c45-4aa9d9454359	4
904458	pravastatin sodium 10 MG Oral Tablet	PSN	64ccb4b5-b77e-4b23-8c74-4685287edb4b	1
904467	pravastatin sodium 20 MG Oral Tablet	PSN	64ccb4b5-b77e-4b23-8c74-4685287edb4b	1
904475	pravastatin sodium 40 MG Oral Tablet	PSN	64ccb4b5-b77e-4b23-8c74-4685287edb4b	1
904481	pravastatin sodium 80 MG Oral Tablet	PSN	ce61f570-2564-429b-8775-157e8e32d378	1
904481	pravastatin sodium 80 MG Oral Tablet	PSN	66589077-5fae-4116-b82b-961de65dd805	1
904481	pravastatin sodium 80 MG Oral Tablet	PSN	64ccb4b5-b77e-4b23-8c74-4685287edb4b	1
904458	pravastatin sodium 10 MG Oral Tablet	SCD	64ccb4b5-b77e-4b23-8c74-4685287edb4b	1
904467	pravastatin sodium 20 MG Oral Tablet	SCD	64ccb4b5-b77e-4b23-8c74-4685287edb4b	1
904475	pravastatin sodium 40 MG Oral Tablet	SCD	64ccb4b5-b77e-4b23-8c74-4685287edb4b	1
904481	pravastatin sodium 80 MG Oral Tablet	SCD	ce61f570-2564-429b-8775-157e8e32d378	1
904481	pravastatin sodium 80 MG Oral Tablet	SCD	66589077-5fae-4116-b82b-961de65dd805	1
904481	pravastatin sodium 80 MG Oral Tablet	SCD	64ccb4b5-b77e-4b23-8c74-4685287edb4b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-1323-1	60505132301	100 TABLET in 1 BOTTLE (60505-1323-1)	100 tablet	2011-07-18	0000-00-00	No	No	Current
60505-1323-5	60505132305	500 TABLET in 1 BOTTLE (60505-1323-5)	500 tablet	2011-07-18	0000-00-00	No	No	Current
60505-1323-7	60505132307	1000 TABLET in 1 BOTTLE (60505-1323-7)	1000 tablet	2011-07-18	0000-00-00	No	No	Current
60505-1323-8	60505132308	5000 TABLET in 1 BOTTLE (60505-1323-8)	5000 tablet	2011-07-18	0000-00-00	No	No	Current
60505-1323-9	60505132309	90 TABLET in 1 BOTTLE (60505-1323-9)	90 tablet	2011-07-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRAVASTATIN SODIUM	Apotex Corp. \| Apotex Inc.	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL	19
PRAVASTATIN SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs \| Apotex Inc.	2026-02-27	HUMAN PRESCRIPTION DRUG LABEL	1
PRAVASTATIN SODIUM	Bryant Ranch Prepack	2026-01-29	HUMAN PRESCRIPTION DRUG LABEL	104
PRAVASTATIN SODIUM	AvPAK	2026-01-09	HUMAN PRESCRIPTION DRUG LABEL	6
PRAVASTATIN SODIUM	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
PRAVASTATIN SODIUM	Bryant Ranch Prepack	2025-11-17	HUMAN PRESCRIPTION DRUG LABEL	106
PRAVASTATIN SODIUM	Bryant Ranch Prepack	2025-11-04	HUMAN PRESCRIPTION DRUG LABEL	13
PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc..	2025-09-10	HUMAN PRESCRIPTION DRUG LABEL	4
PRAVASTATIN	DIRECT RX	2025-01-17	HUMAN PRESCRIPTION DRUG LABEL	5
PRAVASTATIN SODIUM	Bryant Ranch Prepack	2024-11-01	HUMAN PRESCRIPTION DRUG LABEL	104
PRAVASTATIN SODIUM	A-S Medication Solutions	2024-10-23	HUMAN PRESCRIPTION DRUG LABEL	29
PRAVASTATIN SODIUM	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	2
PRAVASTATIN SODIUM	Aphena Pharma Solutions - Tennessee, LLC	2022-03-03	HUMAN PRESCRIPTION DRUG LABEL	1
PRAVASTATIN SODIUM	REMEDYREPACK INC.	2019-07-10	HUMAN PRESCRIPTION DRUG LABEL	1
PRAVASTATIN SODIUM	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-08-23	HUMAN PRESCRIPTION DRUG LABEL	1