PRAVASTATIN SODIUM

Product NDC: 60505-0169
11-digit product format: 605050169
Labeler code: 60505
Product ID: 60505-0169_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: 20 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 42.

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 · 168 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
2026-08-18 06:07:40	2026-07	A076341-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076341-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076341-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076341-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A076341-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076341-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076341-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076341-004	AB	1	`caaa826d4ba7…`
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…`

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	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 · 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
60505-0169-1	PRAVASTATIN SODIUM	100 in 1 BOTTLE	TABLET	100	18
60505-0169-2	PRAVASTATIN SODIUM	20000 in 1 BOTTLE	TABLET	20000	18
60505-0169-5	PRAVASTATIN SODIUM	500 in 1 BOTTLE	TABLET	500	18
60505-0169-7	PRAVASTATIN SODIUM	1000 in 1 BOTTLE	TABLET	1000	18
60505-0169-9	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
60505-0169-7	EA - Each	60505-0169	33a35503-01a8-44cd-bfbf-616d4d65b6bb	1	2012-07-24
60505-0169-9	EA - Each	60505-0169	38fd2279-95e2-4fa3-b78e-b58f41bef585	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
PRAVASTATIN SODIUM	ACTIVE INGREDIENT	3M8608UQ61	PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]	5
PRAVASTATIN	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRAVASTATIN SODIUM TABLET [MAJOR PHARMACEUTICALS]	5
pravastatin sodium	ACTIVE INGREDIENT	3M8608UQ61	PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]	2
pravastatin	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]	2
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]	2
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]	2
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]	2
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PRAVASTATIN SODIUM TABLET [GOLDEN STATE MEDICAL SUPPLY]	2
PRAVASTATIN SODIUM	ACTIVE INGREDIENT	3M8608UQ61	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
pravastatin sodium	ACTIVE INGREDIENT	3M8608UQ61	PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
PRAVASTATIN	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
pravastatin	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MEGLUMINE	INACTIVE INGREDIENT	6HG8UB2MUY	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-0169	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): 60505-0169
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
904467	pravastatin sodium 20 MG Oral Tablet	PSN	8d1bf7a5-bf11-47e3-afca-dcc13f2d3068	104
904467	pravastatin sodium 20 MG Oral Tablet	SCD	8d1bf7a5-bf11-47e3-afca-dcc13f2d3068	104
904467	pravastatin sodium 20 MG Oral Tablet	PSN	03e27551-b3bf-47dd-b3ec-cd9a66ace3c4	100
904467	pravastatin sodium 20 MG Oral Tablet	SCD	03e27551-b3bf-47dd-b3ec-cd9a66ace3c4	100
904467	pravastatin sodium 20 MG Oral Tablet	PSN	93b0e546-9e0f-40d1-9b1e-082bf16400a4	27
904475	pravastatin sodium 40 MG Oral Tablet	PSN	93b0e546-9e0f-40d1-9b1e-082bf16400a4	27
904467	pravastatin sodium 20 MG Oral Tablet	SCD	93b0e546-9e0f-40d1-9b1e-082bf16400a4	27
904475	pravastatin sodium 40 MG Oral Tablet	SCD	93b0e546-9e0f-40d1-9b1e-082bf16400a4	27
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
904467	pravastatin sodium 20 MG Oral Tablet	PSN	c5f611aa-9974-422e-a353-5d834a33937c	17
904467	pravastatin sodium 20 MG Oral Tablet	SCD	c5f611aa-9974-422e-a353-5d834a33937c	17
904458	pravastatin sodium 10 MG Oral Tablet	PSN	1d5bce9c-a788-4c52-a69e-c53174b8d061	15
904467	pravastatin sodium 20 MG Oral Tablet	PSN	1d5bce9c-a788-4c52-a69e-c53174b8d061	15
904475	pravastatin sodium 40 MG Oral Tablet	PSN	1d5bce9c-a788-4c52-a69e-c53174b8d061	15
904458	pravastatin sodium 10 MG Oral Tablet	SCD	1d5bce9c-a788-4c52-a69e-c53174b8d061	15
904467	pravastatin sodium 20 MG Oral Tablet	SCD	1d5bce9c-a788-4c52-a69e-c53174b8d061	15
904475	pravastatin sodium 40 MG Oral Tablet	SCD	1d5bce9c-a788-4c52-a69e-c53174b8d061	15
904467	pravastatin sodium 20 MG Oral Tablet	PSN	e4dbaa72-7b3e-4aef-983b-90efb2b343cd	13
904467	pravastatin sodium 20 MG Oral Tablet	SCD	e4dbaa72-7b3e-4aef-983b-90efb2b343cd	13
904458	pravastatin sodium 10 MG Oral Tablet	PSN	e7194af1-6304-4e3e-88ab-0825706a3962	9
904467	pravastatin sodium 20 MG Oral Tablet	PSN	e7194af1-6304-4e3e-88ab-0825706a3962	9
904475	pravastatin sodium 40 MG Oral Tablet	PSN	e7194af1-6304-4e3e-88ab-0825706a3962	9
904458	pravastatin sodium 10 MG Oral Tablet	SCD	e7194af1-6304-4e3e-88ab-0825706a3962	9
904467	pravastatin sodium 20 MG Oral Tablet	SCD	e7194af1-6304-4e3e-88ab-0825706a3962	9
904475	pravastatin sodium 40 MG Oral Tablet	SCD	e7194af1-6304-4e3e-88ab-0825706a3962	9
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	fd76794d-de33-4886-875c-fa05b2639f84	5
904467	pravastatin sodium 20 MG Oral Tablet	PSN	97178675-3691-2d93-e053-2995a90aa5c1	5
904467	pravastatin sodium 20 MG Oral Tablet	PSN	4d2b4607-0a46-4b58-9247-dc448ce258ec	5
904467	pravastatin sodium 20 MG Oral Tablet	PSN	54228087-7ab0-5561-e054-00144ff8d46c	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
904467	pravastatin sodium 20 MG Oral Tablet	SCD	fd76794d-de33-4886-875c-fa05b2639f84	5
904467	pravastatin sodium 20 MG Oral Tablet	SCD	4d2b4607-0a46-4b58-9247-dc448ce258ec	5
904467	pravastatin sodium 20 MG Oral Tablet	SCD	54228087-7ab0-5561-e054-00144ff8d46c	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
904467	pravastatin sodium 20 MG Oral Tablet	PSN	6d42bd30-1f09-49f4-9ec8-31366df1b4b4	4
904467	pravastatin sodium 20 MG Oral Tablet	SCD	6d42bd30-1f09-49f4-9ec8-31366df1b4b4	4
904458	pravastatin sodium 10 MG Oral Tablet	PSN	64ccb4b5-b77e-4b23-8c74-4685287edb4b	1
904467	pravastatin sodium 20 MG Oral Tablet	PSN	e4e9610a-765b-4237-a598-0f4b27a4553e	1
904467	pravastatin sodium 20 MG Oral Tablet	PSN	64ccb4b5-b77e-4b23-8c74-4685287edb4b	1
904475	pravastatin sodium 40 MG Oral Tablet	PSN	e4e9610a-765b-4237-a598-0f4b27a4553e	1
904475	pravastatin sodium 40 MG Oral Tablet	PSN	64ccb4b5-b77e-4b23-8c74-4685287edb4b	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
904467	pravastatin sodium 20 MG Oral Tablet	SCD	e4e9610a-765b-4237-a598-0f4b27a4553e	1
904475	pravastatin sodium 40 MG Oral Tablet	SCD	64ccb4b5-b77e-4b23-8c74-4685287edb4b	1
904475	pravastatin sodium 40 MG Oral Tablet	SCD	e4e9610a-765b-4237-a598-0f4b27a4553e	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
60505-0169-1	60505016901	100 TABLET in 1 BOTTLE (60505-0169-1)	100 tablet	2011-07-18	0000-00-00	No	No	Current
60505-0169-2	60505016902	20000 TABLET in 1 BOTTLE (60505-0169-2)	20000 tablet	2011-07-18	0000-00-00	No	No	Current
60505-0169-5	60505016905	500 TABLET in 1 BOTTLE (60505-0169-5)	500 tablet	2011-07-18	0000-00-00	No	No	Current
60505-0169-7	60505016907	1000 TABLET in 1 BOTTLE (60505-0169-7)	1000 tablet	2011-07-18	0000-00-00	No	No	Current
60505-0169-9	60505016909	90 TABLET in 1 BOTTLE (60505-0169-9)	90 tablet	2011-07-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	2026-08-17	HUMAN PRESCRIPTION DRUG LABEL	5
PRAVASTATIN SODIUM	Apotex Corp. \| Apotex Inc.	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL	19
PRAVASTATIN SODIUM	REMEDYREPACK INC.	2026-07-16	HUMAN PRESCRIPTION DRUG LABEL	14
PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	2026-07-07	HUMAN PRESCRIPTION DRUG LABEL	18
PRAVASTATIN SODIUM	Bryant Ranch Prepack	2026-06-04	HUMAN PRESCRIPTION DRUG LABEL	105
PRAVASTATIN SODIUM	A-S Medication Solutions	2026-04-13	HUMAN PRESCRIPTION DRUG LABEL	27
PRAVASTATIN SODIUM	Major Pharmaceuticals	2026-03-02	HUMAN PRESCRIPTION DRUG LABEL	15
PRAVASTATIN SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs \| Apotex Inc.	2026-02-27	HUMAN PRESCRIPTION DRUG LABEL	1
PRAVASTATIN SODIUM	AvPAK	2026-01-09	HUMAN PRESCRIPTION DRUG LABEL	6
PRAVASTATIN SODIUM	A-S Medication Solutions	2025-12-10	HUMAN PRESCRIPTION DRUG LABEL	5
PRAVASTATIN SODIUM	Bryant Ranch Prepack	2025-10-30	HUMAN PRESCRIPTION DRUG LABEL	100
PRAVASTATIN	DIRECT RX	2025-01-17	HUMAN PRESCRIPTION DRUG LABEL	5
Pravastatin Sodium Tablets, USP 10 mg, 20 mg, 40 mg and 80 mg	Lake Erie Medical DBA Quality Care Products LLC	2024-12-11	HUMAN PRESCRIPTION DRUG LABEL	9
PRAVASTATIN SODIUM	NuCare Pharmaceuticals, Inc.	2024-07-10	HUMAN PRESCRIPTION DRUG LABEL	5
PRAVASTATIN SODIUM	Bryant Ranch Prepack	2024-04-02	HUMAN PRESCRIPTION DRUG LABEL	102
PRAVASTATIN SODIUM	Proficient Rx LP	2023-08-01	HUMAN PRESCRIPTION DRUG LABEL	5