PRAVASTATIN SODIUM TABLETS

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-12-03
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 11
Source: legacy-cache
Hydrated at: 2026-08-01 20:47:24

Label at a glance#

Productpravastatin sodium

Active ingredientPRAVASTATIN SODIUM

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-739-05 in bottle of 500 tablets

Pravastatin Sodium Tablets USP, 10 mg

R_xonly

500 tablets

NDC 65841-740-05 in bottle of 500 tablets

Pravastatin Sodium Tablets USP, 20 mg

R_xonly

500 tablets

NDC 65841-741-05 in bottle of 500 tablets

Pravastatin Sodium Tablets USP, 40 mg

R_xonly

500 tablets

NDC 65841-742-05 in bottle of 500 tablets

Pravastatin Sodium Tablets USP, 80 mg

R_xonly

500 tablets

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PRAVASTATIN SODIUM	ACTIVE INGREDIENT	3M8608UQ61	4
PRAVASTATIN	ACTIVE MOIETY	KXO2KT9N0G	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	4
POLYOXYL 35 CASTOR OIL	INACTIVE INGREDIENT	6D4M1DAL6O	4
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

pravastatin sodium
PRAVASTATIN
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
POLYOXYL 35 CASTOR OIL
SODIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
ANHYDROUS LACTOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65841-739	65841-739-16, 65841-739-05
65841-740	65841-740-16, 65841-740-05, 65841-740-10
65841-741	65841-741-16, 65841-741-05
65841-742	65841-742-16, 65841-742-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PRAVASTATIN SODIUM	3M8608UQ61	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYOXYL 35 CASTOR OIL	6D4M1DAL6O	IACT
SODIUM CARBONATE	45P3261C7T	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
PRAVASTATIN SODIUM	3M8608UQ61	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYOXYL 35 CASTOR OIL	6D4M1DAL6O	IACT
SODIUM CARBONATE	45P3261C7T	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
PRAVASTATIN SODIUM	3M8608UQ61	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYOXYL 35 CASTOR OIL	6D4M1DAL6O	IACT
SODIUM CARBONATE	45P3261C7T	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
PRAVASTATIN SODIUM	3M8608UQ61	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYOXYL 35 CASTOR OIL	6D4M1DAL6O	IACT
SODIUM CARBONATE	45P3261C7T	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 152 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, EXTENDED RELEASE / ORAL		392 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	TABLET, EFFERVESCENT / ORAL		430 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	TABLET, FILM COATED / ORAL		30 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POLYOXYL 35 CASTOR OIL	POLYOXYL 35 CASTOR OIL	6D4M1DAL6O	INJECTION, EMULSION / INTRAMUSCULAR		1750 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
POLYOXYL 35 CASTOR OIL	POLYOXYL 35 CASTOR OIL	6D4M1DAL6O	INJECTION, EMULSION / SUBCUTANEOUS		1750 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	INJECTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	GUM, CHEWING / ORAL		240 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	POWDER, FOR SUSPENSION / ORAL		469 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	TABLET, EXTENDED RELEASE / ORAL		80 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	TABLET / BUCCAL		20 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POLYOXYL 35 CASTOR OIL	POLYOXYL 35 CASTOR OIL	6D4M1DAL6O	TABLET, EXTENDED RELEASE / ORAL	5.2 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
POLYOXYL 35 CASTOR OIL	POLYOXYL 35 CASTOR OIL	6D4M1DAL6O	INJECTION, EMULSION / INTRAVENOUS		350 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / SUBLINGUAL	43.2 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	INJECTION / INTRAVENOUS	241 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	TROCHE / ORAL		375 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, COATED PELLETS / ORAL		198 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POLYOXYL 35 CASTOR OIL	POLYOXYL 35 CASTOR OIL	6D4M1DAL6O	TABLET / ORAL		4 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE, FOR SUSPENSION / ORAL		14 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, FOR SUSPENSION / ORAL		15 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
POLYOXYL 35 CASTOR OIL	POLYOXYL 35 CASTOR OIL	6D4M1DAL6O	INJECTION, SOLUTION / INTRAVENOUS	52.75 %w/v		Exact identifier — unii candidate 14 equally ranked IID candidates
POLYOXYL 35 CASTOR OIL	POLYOXYL 35 CASTOR OIL	6D4M1DAL6O	SOLUTION / INTRAVESICAL		10588 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	POWDER / ORAL		5 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, ORALLY DISINTEGRATING / ORAL		410 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, FILM COATED / ORAL		2906 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
POLYOXYL 35 CASTOR OIL	POLYOXYL 35 CASTOR OIL	6D4M1DAL6O	SUSPENSION / ORAL	0.4 mg/1ml		Exact identifier — unii candidate 14 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		1576 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	CAPSULE, EXTENDED RELEASE / ORAL		869 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		375 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / BUCCAL		18 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, DELAYED RELEASE / ORAL		280 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	DROPS / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	25 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		1247 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SUSPENSION / ORAL		4441 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		615 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IMPLANT / INTRAVITREAL	1.66 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, DELAYED RELEASE / ORAL	789.6 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	GRANULE / ORAL		150 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	630 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, COATED / ORAL		560 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	INJECTION / INTRAMUSCULAR	1 %w/v		Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
POLYOXYL 35 CASTOR OIL	POLYOXYL 35 CASTOR OIL	6D4M1DAL6O	SOLUTION/ DROPS / OPHTHALMIC	5 %w/v		Exact identifier — unii candidate 14 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	TABLET, DELAYED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	GUM, CHEWING / BUCCAL		720 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, FOR SUSPENSION / ORAL		278 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, CHEWABLE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION, EXTENDED RELEASE / ORAL		1120 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET / BUCCAL		48 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE / ORAL		29520 mg	Exact identifier — unii candidate 28 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A077751-001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	10MG	TABLET / ORAL		2008-04-30
A077751-002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-04-30
A077751-003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-04-30
A077751-004	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077751-002	AB
A077751-003	AB
A077751-004	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 · 176 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
2026-10-15 13:18:30	2026-09	A077751-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL		2008-04-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077751-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-04-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077751-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-04-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077751-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-04-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077751-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL		2008-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077751-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077751-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077751-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077751-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL		2008-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077751-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077751-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077751-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077751-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL		2008-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077751-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077751-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077751-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077751-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL		2008-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077751-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077751-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077751-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077751-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL		2008-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077751-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077751-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077751-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077751-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL		2008-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077751-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077751-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077751-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077751-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL		2008-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077751-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077751-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077751-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077751-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL		2008-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077751-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077751-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077751-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077751-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL		2008-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077751-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2008-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077751-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2008-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077751-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2008-04-30	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 136 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A077751-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077751-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077751-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077751-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077751-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077751-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077751-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077751-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077751-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077751-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077751-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077751-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077751-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077751-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077751-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077751-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077751-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077751-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077751-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077751-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077751-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077751-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077751-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077751-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077751-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077751-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077751-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077751-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077751-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077751-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077751-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077751-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077751-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077751-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077751-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077751-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077751-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077751-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077751-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077751-002	AB	1	`79d66fd596c7…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f4fc6495-dec3-41b0-9d63-100633434e38			187997be-2dbf-40af-885f-16df6ba9ae46	2025-05-05		Exact identifier spl set id: 187997be-2dbf-40af-885f-16df6ba9ae46

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.