PRAVASTATIN SODIUM

Product NDC: 16729-011
11-digit product format: 167290011
Labeler code: 16729
Product ID: 16729-011_438f9112-0851-75e1-e063-6294a90a675c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PRAVASTATIN SODIUM
Dosage form: TABLET
Route: ORAL
Labeler: Accord Healthcare Inc.
Application: ANDA207068
Marketing category: ANDA
Marketing start: 2017-02-16
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
A207068-001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17
A207068-002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17
A207068-003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17
A207068-004	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A207068-001	AB
A207068-002	AB
A207068-003	AB
A207068-004	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	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207068-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2016-11-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207068-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2016-11-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207068-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2016-11-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207068-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2016-11-17	`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	A207068-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207068-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207068-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207068-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207068-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207068-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207068-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207068-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207068-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207068-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207068-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207068-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207068-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207068-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207068-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207068-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207068-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207068-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207068-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207068-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207068-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207068-004	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
6c011348-a236-47d3-bbef-3e0b956dd080	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
36361c23-a766-1581-d616-2080c781a50c	Product name	5	20190314
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16729-011-15	PRAVASTATIN SODIUM	90 in 1 BOTTLE	TABLET	90	10
16729-011-16	PRAVASTATIN SODIUM	500 in 1 BOTTLE	TABLET	500	10
16729-011-17	PRAVASTATIN SODIUM	1000 in 1 BOTTLE	TABLET	1000	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-011-15	EA - Each	16729-011	4e4aed0b-0227-4777-9c1a-8231268e5f83	1	2017-03-06
16729-011-16	EA - Each	16729-011	e9787137-535b-42fd-ac7e-99380b47fbc0	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-011	PRAVASTATIN SODIUM TABLET [ACCORD HEALTHCARE INC.]	9	Current NDC, Legacy NDC, 3 package rows	20240103_6c011348-a236-47d3-bbef-3e0b956dd080.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	2ded7e5e-c377-4495-a045-f1c57b90c5db	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207068 application number: ANDA207068
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	PD-Rx Pharmaceuticals, Inc.	46fdf929-c961-4dd9-8865-8eb4adaa259a	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207068 application number: ANDA207068
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	daacdad5-f75d-4f9f-b623-8071f3bef91e	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207068 application number: ANDA207068
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Accord Healthcare Inc.	6c011348-a236-47d3-bbef-3e0b956dd080	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207068 application number: ANDA207068 ndc (product): 16729-011
Pravastatin Sodium	PRAVASTATIN SODIUM	Direct_Rx	7f814fd9-7b35-67da-e053-2a91aa0a39dc	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207068 application number: ANDA207068
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Proficient Rx LP	63ca6179-6ae3-4f0b-bdca-50d200317921	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207068 application number: ANDA207068

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	6c011348-a236-47d3-bbef-3e0b956dd080	10
904467	pravastatin sodium 20 MG Oral Tablet	PSN	6c011348-a236-47d3-bbef-3e0b956dd080	10
904475	pravastatin sodium 40 MG Oral Tablet	PSN	6c011348-a236-47d3-bbef-3e0b956dd080	10
904481	pravastatin sodium 80 MG Oral Tablet	PSN	6c011348-a236-47d3-bbef-3e0b956dd080	10
904458	pravastatin sodium 10 MG Oral Tablet	SCD	6c011348-a236-47d3-bbef-3e0b956dd080	10
904467	pravastatin sodium 20 MG Oral Tablet	SCD	6c011348-a236-47d3-bbef-3e0b956dd080	10
904475	pravastatin sodium 40 MG Oral Tablet	SCD	6c011348-a236-47d3-bbef-3e0b956dd080	10
904481	pravastatin sodium 80 MG Oral Tablet	SCD	6c011348-a236-47d3-bbef-3e0b956dd080	10
904481	pravastatin sodium 80 MG Oral Tablet	PSN	7f80cd52-26f7-34ed-e053-2a91aa0adf47	1
904481	pravastatin sodium 80 MG Oral Tablet	SCD	7f80cd52-26f7-34ed-e053-2a91aa0adf47	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-011-15	16729001115	90 TABLET in 1 BOTTLE (16729-011-15)	90 tablet	2017-02-16	0000-00-00	No	No	Current
16729-011-16	16729001116	500 TABLET in 1 BOTTLE (16729-011-16)	500 tablet	2017-02-16	0000-00-00	No	No	Current
16729-011-17	16729001117	1000 in 1 BOTTLE						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRAVASTATIN SODIUM	Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2025-11-14	HUMAN PRESCRIPTION DRUG LABEL	10
PRAVASTATIN SODIUM	Preferred Pharmaceuticals Inc.	2020-08-20	HUMAN PRESCRIPTION DRUG LABEL	2
PRAVASTATIN SODIUM	REMEDYREPACK INC.	2019-10-31	HUMAN PRESCRIPTION DRUG LABEL	3
Pravastatin Sodium	Direct_Rx	2019-01-15	HUMAN PRESCRIPTION DRUG LABEL	1