Pravastatin Sodium

Product NDC: 0093-0771
11-digit product format: 000930771
Labeler code: 0093
Product ID: 0093-0771_72579e23-23ef-4ab7-ad64-24d5ea7997eb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pravastatin Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA076056
Marketing category: ANDA
Marketing start: 2006-04-25
Marketing end: 2026-09-30
Substance: PRAVASTATIN SODIUM
Active strength: 10 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0093-0771	0093-0771-98	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 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	A076056-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076056-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076056-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-04-24	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A076056-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076056-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076056-003	AB	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Pravastatin Sodium

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRAVASTATIN SODIUM	10 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
904458	Internal RxNorm lookup
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
99e0e848-f8f3-4b42-b880-8fbc42633948	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
0093-0771-10	Pravastatin Sodium	1000 in 1 BOTTLE	TABLET	1000		27
0093-0771-98	Pravastatin Sodium	90 in 1 BOTTLE	TABLET	90		27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-0771-10	EA - Each	0093-0771	5354fd0c-4932-4112-81a6-62070ecce061	1	2012-07-24
0093-0771-98	EA - Each	0093-0771	475fbada-de30-426a-89e4-e8bdcbdc8b97	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 [TEVA PHARMACEUTICALS USA INC]	12
PRAVASTATIN	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]	12
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]	12
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	PRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]	12
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]	12
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	PRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC]	12
PRAVASTATIN SODIUM	ACTIVE INGREDIENT	3M8608UQ61	PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.]	9
PRAVASTATIN	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.]	9
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.]	9
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.]	9
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.]	9
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.]	9
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.]	9
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.]	9
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.]	9
PRAVASTATIN SODIUM	ACTIVE INGREDIENT	3M8608UQ61	PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]	2
PRAVASTATIN	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]	2
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]	2
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]	2
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]	2
PRAVASTATIN SODIUM	ACTIVE INGREDIENT	3M8608UQ61	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
PRAVASTATIN SODIUM	ACTIVE INGREDIENT	3M8608UQ61	PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	1
PRAVASTATIN	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	1
PRAVASTATIN	ACTIVE MOIETY	KXO2KT9N0G	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	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
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	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 [PHYSICIANS TOTAL CARE, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-0771	PRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA, INC.]	27	Current NDC, Legacy NDC, 2 package rows	20250507_99e0e848-f8f3-4b42-b880-8fbc42633948.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
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 ndc (product): 0093-0771
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
904458	pravastatin sodium 10 MG Oral Tablet	PSN	99e0e848-f8f3-4b42-b880-8fbc42633948	27
904467	pravastatin sodium 20 MG Oral Tablet	PSN	99e0e848-f8f3-4b42-b880-8fbc42633948	27
904475	pravastatin sodium 40 MG Oral Tablet	PSN	99e0e848-f8f3-4b42-b880-8fbc42633948	27
904458	pravastatin sodium 10 MG Oral Tablet	SCD	99e0e848-f8f3-4b42-b880-8fbc42633948	27
904467	pravastatin sodium 20 MG Oral Tablet	SCD	99e0e848-f8f3-4b42-b880-8fbc42633948	27
904475	pravastatin sodium 40 MG Oral Tablet	SCD	99e0e848-f8f3-4b42-b880-8fbc42633948	27
904458	pravastatin sodium 10 MG Oral Tablet	PSN	ad386ed4-a284-4da5-b79a-3c0f4165057a	12
904458	pravastatin sodium 10 MG Oral Tablet	SCD	ad386ed4-a284-4da5-b79a-3c0f4165057a	12
904458	pravastatin sodium 10 MG Oral Tablet	PSN	a5ca8004-9a18-4030-a56c-8938c4823c64	1
904458	pravastatin sodium 10 MG Oral Tablet	PSN	c129f662-9ae7-45b6-9a02-15b569e051fc	1
904467	pravastatin sodium 20 MG Oral Tablet	PSN	a5ca8004-9a18-4030-a56c-8938c4823c64	1
904467	pravastatin sodium 20 MG Oral Tablet	PSN	c129f662-9ae7-45b6-9a02-15b569e051fc	1
904475	pravastatin sodium 40 MG Oral Tablet	PSN	a5ca8004-9a18-4030-a56c-8938c4823c64	1
904475	pravastatin sodium 40 MG Oral Tablet	PSN	c129f662-9ae7-45b6-9a02-15b569e051fc	1
904481	pravastatin sodium 80 MG Oral Tablet	PSN	a5ca8004-9a18-4030-a56c-8938c4823c64	1
904458	pravastatin sodium 10 MG Oral Tablet	SCD	a5ca8004-9a18-4030-a56c-8938c4823c64	1
904458	pravastatin sodium 10 MG Oral Tablet	SCD	c129f662-9ae7-45b6-9a02-15b569e051fc	1
904467	pravastatin sodium 20 MG Oral Tablet	SCD	a5ca8004-9a18-4030-a56c-8938c4823c64	1
904467	pravastatin sodium 20 MG Oral Tablet	SCD	c129f662-9ae7-45b6-9a02-15b569e051fc	1
904475	pravastatin sodium 40 MG Oral Tablet	SCD	a5ca8004-9a18-4030-a56c-8938c4823c64	1
904475	pravastatin sodium 40 MG Oral Tablet	SCD	c129f662-9ae7-45b6-9a02-15b569e051fc	1
904481	pravastatin sodium 80 MG Oral Tablet	SCD	a5ca8004-9a18-4030-a56c-8938c4823c64	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-0771-10	00093077110	1000 TABLET in 1 BOTTLE (0093-0771-10)	1000 tablet	2008-03-07	2026-09-30	No	No	Current
0093-0771-98	00093077198	90 TABLET in 1 BOTTLE (0093-0771-98)	90 tablet	2006-04-25	2026-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pravastatin Sodium	Northwind Health Company, LLC	2025-12-26	HUMAN PRESCRIPTION DRUG LABEL	3
Pravastatin Sodium	REMEDYREPACK INC.	2024-05-09	HUMAN PRESCRIPTION DRUG LABEL	1
Pravastatin Sodium	Teva Pharmaceuticals USA, Inc.	2024-01-01	HUMAN PRESCRIPTION DRUG LABEL	27
Pravastatin Sodium	AvKARE	2023-09-12	HUMAN PRESCRIPTION DRUG LABEL	12
Pravastatin Sodium	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	6
Pravastatin Sodium	International Laboratories, LLC	2017-03-29	HUMAN PRESCRIPTION DRUG LABEL	12
PRAVASTATIN SODIUM TABLETS Rx only	State of Florida DOH Central Pharmacy	2010-06-01	HUMAN PRESCRIPTION DRUG LABEL	1
Pravastatin Sodium - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2010-01-12	HUMAN PRESCRIPTION DRUG LABEL	1