PRAVASTATIN SODIUM

Product NDC: 72189-059
11-digit product format: 721890059
Labeler code: 72189
Product ID: 72189-059_2be8f6ba-328a-86ab-e063-6394a90acb89
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PRAVASTATIN SODIUM
Dosage form: TABLET
Route: ORAL
Labeler: DIRECT RX
Application: ANDA076341
Marketing category: ANDA
Marketing start: 2019-11-11
Substance: PRAVASTATIN SODIUM
Active strength: 10 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	72189-059		U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-059	72189-059-90	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 172 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
2026-09-14 22:38:34	2026-08	A076341-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2006-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076341-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2006-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076341-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2006-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076341-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2007-12-28	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076341-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076341-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076341-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076341-004	AB	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

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

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	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 · 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
97178675-3691-2d93-e053-2995a90aa5c1	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
72189-059-90	PRAVASTATIN SODIUM	90 in 1 BOTTLE	TABLET	90		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-059-90	EA - Each	72189-059	76aadf11-9a8f-48d3-a300-67b58cb46ee2	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-059	PRAVASTATIN SODIUM TABLET [DIRECT RX]	5	Current NDC, Legacy NDC, 1 package rows	20250119_97178675-3691-2d93-e053-2995a90aa5c1.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 2 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Northwind Health Company, LLC	db5b8821-dca8-9322-e053-2a95a90abdc3	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Northwind Health Company, LLC	df75b04e-3e85-9705-e053-2995a90af83f	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	fd76794d-de33-4886-875c-fa05b2639f84	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Coupler LLC	4573c42b-6d4a-e001-e063-6294a90acea1	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	12943de2-c7e9-4651-89f3-fc6cb5276676	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	97123f09-b5ad-45c2-8bb7-f50566b56b08	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	2ba7af14-9c87-4eb0-84c9-7e895cd75fae	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	abcfc343-7ac9-4fce-b368-fd05cf14b0e2	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	03e27551-b3bf-47dd-b3ec-cd9a66ace3c4	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Aphena Pharma Solutions - Tennessee, LLC	2e5cfae8-20b8-1fea-e063-6394a90a4e17	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	7b900a28-f20e-49d5-98a9-5513fee0a901	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	DIRECT RX	97178675-3691-2d93-e053-2995a90aa5c1	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341 ndc (product): 72189-059
Pravastatin Sodium	PRAVASTATIN SODIUM	Lake Erie Medical DBA Quality Care Products LLC	e7194af1-6304-4e3e-88ab-0825706a3962	2024-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	7b4ef7a8-47e5-428f-91de-7307dcbb9167	2024-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	NuCare Pharmaceuticals, Inc.	54228087-7ab0-5561-e054-00144ff8d46c	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	NuCare Pharmaceuticals,Inc.	548bdd9f-dcc6-28c7-e054-00144ff8d46c	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	NuCare Pharmaceuticals,Inc.	8e9d5896-0b7c-dbd4-e053-2a95a90ae2f6	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	NuCare Pharmaceuticals,Inc.	8ed7879d-988c-1a27-e053-2995a90a0361	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076341 application number: ANDA076341
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Proficient Rx LP	4d2b4607-0a46-4b58-9247-dc448ce258ec	2023-08-01	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
904458	pravastatin sodium 10 MG Oral Tablet	PSN	97178675-3691-2d93-e053-2995a90aa5c1	5
904467	pravastatin sodium 20 MG Oral Tablet	PSN	97178675-3691-2d93-e053-2995a90aa5c1	5
904475	pravastatin sodium 40 MG Oral Tablet	PSN	97178675-3691-2d93-e053-2995a90aa5c1	5
904481	pravastatin sodium 80 MG Oral Tablet	PSN	97178675-3691-2d93-e053-2995a90aa5c1	5
904458	pravastatin sodium 10 MG Oral Tablet	SCD	97178675-3691-2d93-e053-2995a90aa5c1	5
904467	pravastatin sodium 20 MG Oral Tablet	SCD	97178675-3691-2d93-e053-2995a90aa5c1	5
904475	pravastatin sodium 40 MG Oral Tablet	SCD	97178675-3691-2d93-e053-2995a90aa5c1	5
904481	pravastatin sodium 80 MG Oral Tablet	SCD	97178675-3691-2d93-e053-2995a90aa5c1	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-059-90	72189005990	90 TABLET in 1 BOTTLE (72189-059-90)	90 tablet	2019-11-11	0000-00-00	No	No	Current