Pravastatin Sodium

Product NDC: 68462-198
11-digit product format: 684620198
Labeler code: 68462
Product ID: 68462-198_a6e006b3-4256-4cbb-8ad1-b71f363430cd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pravastatin Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA077987
Marketing category: ANDA
Marketing start: 2007-12-28
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: 2026-12-31
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
A077987-001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2007-05-11
A077987-002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2007-05-11
A077987-003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2007-05-11
A077987-004	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
A077987-001	AB
A077987-002	AB
A077987-003	AB
A077987-004	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	A077987-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2007-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077987-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2007-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077987-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2007-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077987-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077987-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2007-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077987-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2007-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077987-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2007-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077987-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077987-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2007-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077987-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2007-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077987-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2007-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077987-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077987-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2007-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077987-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2007-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077987-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2007-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077987-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077987-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2007-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077987-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2007-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077987-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2007-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077987-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077987-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2007-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077987-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2007-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077987-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2007-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077987-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077987-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2007-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077987-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2007-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077987-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2007-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077987-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077987-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2007-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077987-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2007-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077987-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2007-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077987-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077987-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2007-05-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077987-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2007-05-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077987-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2007-05-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077987-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077987-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2007-05-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077987-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2007-05-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077987-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2007-05-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077987-004	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	A077987-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077987-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077987-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077987-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077987-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077987-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077987-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077987-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077987-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077987-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077987-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077987-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077987-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077987-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077987-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077987-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077987-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077987-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077987-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077987-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077987-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077987-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077987-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077987-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077987-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077987-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077987-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077987-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077987-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077987-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077987-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077987-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077987-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077987-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077987-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077987-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077987-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077987-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077987-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077987-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Pravastatin Sodium
Listing expiration: 2026-12-31

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
6ca01de3-a0f9-4cfb-b36a-723c7c42e2a4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
36361c23-a766-1581-d616-2080c781a50c	Product name	5	20190314
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68462-198-05	Pravastatin Sodium	500 in 1 BOTTLE	TABLET	500		11
68462-198-90	Pravastatin Sodium	90 in 1 BOTTLE	TABLET	90		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-198-05	EA - Each	68462-198	3cf4cdd1-941e-494b-9c65-52b5b407a6e5	1	2012-07-24
68462-198-90	EA - Each	68462-198	f33174c1-7ce5-4eab-bc09-baa92f550803	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 [GLENMARK PHARMACEUTICALS INC., USA]	5
PRAVASTATIN	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	5
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	5
MEGLUMINE	INACTIVE INGREDIENT	6HG8UB2MUY	PRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	5
PRAVASTATIN SODIUM	ACTIVE INGREDIENT	3M8608UQ61	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
PRAVASTATIN	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	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
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	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
68462-198	PRAVASTATIN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	11	Current NDC, Legacy NDC, 2 package rows	20220811_6ca01de3-a0f9-4cfb-b36a-723c7c42e2a4.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	American Health Packaging	97f826f0-b5c5-410c-b1f0-523873981e8d	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077987 application number: ANDA077987
Pravastatin Sodium	PRAVASTATIN SODIUM	Northwind Health Company, LLC	db0e9c21-dc25-629a-e053-2a95a90a5ac3	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077987 application number: ANDA077987
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	45f0fd53-7160-4361-ba0b-3401095441c4	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077987 application number: ANDA077987
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	635062df-9a84-4ff8-874c-dcee581a5555	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077987 application number: ANDA077987
Pravastatin Sodium	PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	095ac6fd-fdfb-4207-b15d-8e93bee378c3	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077987 application number: ANDA077987
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	4015f184-b57e-4d32-9cef-15c6e1cefe24	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077987 application number: ANDA077987
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	b7a84cc1-f6e4-40be-9e68-cf7d43bbd617	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077987 application number: ANDA077987
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	bdf02140-3647-498e-ba0a-f4ca920b4e90	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077987 application number: ANDA077987
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	88e3b5b1-8379-492b-8902-af77f87ad995	2025-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077987 application number: ANDA077987
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Coupler LLC	2e0655ba-b1ba-789b-e063-6294a90a0a19	2025-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077987 application number: ANDA077987
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Coupler LLC	2e07ad78-1059-e0ec-e063-6394a90a9bff	2025-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077987 application number: ANDA077987
Pravastatin Sodium	PRAVASTATIN SODIUM	American Health Packaging	056475c8-59c2-469c-9175-7162065726f5	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077987 application number: ANDA077987
Pravastatin Sodium	PRAVASTATIN SODIUM	Quality Care Products, LLC	465dc828-966e-4bb4-b935-ef26583dd4e6	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077987 application number: ANDA077987
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	27ba8a69-b5aa-40eb-89f7-6bf2c1fcceae	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077987 application number: ANDA077987
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	CIPLA USA INC.	678dfe58-3200-4c3d-9718-365aa47d070f	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077987 application number: ANDA077987
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	a75de063-c751-4647-bb9e-d4050c1e31fc	2023-12-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077987 application number: ANDA077987
Pravastatin Sodium	PRAVASTATIN SODIUM	NorthStar RxLLC	ce15ad07-3286-478f-9f30-1db6a45ed402	2023-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077987 application number: ANDA077987
Pravastatin Sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	3a08fa97-24c3-4a4a-a0aa-26e50cbfc52d	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077987 application number: ANDA077987
Pravastatin Sodium	PRAVASTATIN SODIUM	Glenmark Pharmaceuticals Inc., USA	6ca01de3-a0f9-4cfb-b36a-723c7c42e2a4	2022-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077987 application number: ANDA077987 ndc (product): 68462-198

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
904458	pravastatin sodium 10 MG Oral Tablet	PSN	6ca01de3-a0f9-4cfb-b36a-723c7c42e2a4	11
904467	pravastatin sodium 20 MG Oral Tablet	PSN	6ca01de3-a0f9-4cfb-b36a-723c7c42e2a4	11
904475	pravastatin sodium 40 MG Oral Tablet	PSN	6ca01de3-a0f9-4cfb-b36a-723c7c42e2a4	11
904481	pravastatin sodium 80 MG Oral Tablet	PSN	6ca01de3-a0f9-4cfb-b36a-723c7c42e2a4	11
904458	pravastatin sodium 10 MG Oral Tablet	SCD	6ca01de3-a0f9-4cfb-b36a-723c7c42e2a4	11
904467	pravastatin sodium 20 MG Oral Tablet	SCD	6ca01de3-a0f9-4cfb-b36a-723c7c42e2a4	11
904475	pravastatin sodium 40 MG Oral Tablet	SCD	6ca01de3-a0f9-4cfb-b36a-723c7c42e2a4	11
904481	pravastatin sodium 80 MG Oral Tablet	SCD	6ca01de3-a0f9-4cfb-b36a-723c7c42e2a4	11
904481	pravastatin sodium 80 MG Oral Tablet	PSN	3a08fa97-24c3-4a4a-a0aa-26e50cbfc52d	3
904481	pravastatin sodium 80 MG Oral Tablet	SCD	3a08fa97-24c3-4a4a-a0aa-26e50cbfc52d	3
904458	pravastatin sodium 10 MG Oral Tablet	PSN	ea2d1275-8437-4979-8199-24eb9678be94	1
904481	pravastatin sodium 80 MG Oral Tablet	PSN	ea2d1275-8437-4979-8199-24eb9678be94	1
904458	pravastatin sodium 10 MG Oral Tablet	SCD	ea2d1275-8437-4979-8199-24eb9678be94	1
904481	pravastatin sodium 80 MG Oral Tablet	SCD	ea2d1275-8437-4979-8199-24eb9678be94	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-198-05	68462019805	500 TABLET in 1 BOTTLE (68462-198-05)	500 tablet	2007-12-28	0000-00-00	No	No	Current
68462-198-90	68462019890	90 TABLET in 1 BOTTLE (68462-198-90)	90 tablet	2007-12-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pravastatin Sodium	A-S Medication Solutions	2023-02-06	HUMAN PRESCRIPTION DRUG LABEL	3
Pravastatin Sodium	NCS HealthCare of KY, LLC dba Vangard Labs \| Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2022-09-06	HUMAN PRESCRIPTION DRUG LABEL	3
Pravastatin Sodium	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2022-07-08	HUMAN PRESCRIPTION DRUG LABEL	11
Pravastatin Sodium	REMEDYREPACK INC.	2020-03-31	HUMAN PRESCRIPTION DRUG LABEL	5
Pravastatin Sodium Tablets	State of Florida DOH Central Pharmacy	2010-06-01	HUMAN PRESCRIPTION DRUG LABEL	1