PRAVASTATIN SODIUM

Product NDC: 63629-8910
Requested package NDC: 63629-8910-1
11-digit product format: 636298910
Labeler code: 63629
Product ID: 63629-8910_3375498b-534d-e8da-e063-6294a90a321b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PRAVASTATIN SODIUM
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA209869
Marketing category: ANDA
Marketing start: 2021-02-01
Substance: PRAVASTATIN SODIUM
Active strength: 40 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
A209869-001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13
A209869-002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13
A209869-003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13
A209869-004	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209869-001	AB
A209869-002	AB
A209869-003	AB
A209869-004	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A209869-001	PRAVASTATIN SODIUM	10MG	TABLET / ORAL	AB	2018-04-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209869-002	PRAVASTATIN SODIUM	20MG	TABLET / ORAL	AB	2018-04-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209869-003	PRAVASTATIN SODIUM	40MG	TABLET / ORAL	AB	2018-04-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209869-004	PRAVASTATIN SODIUM	80MG	TABLET / ORAL	AB	2018-04-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A209869-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209869-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209869-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209869-004	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ca7a4143-0091-4cd5-9061-cb05cc84ea4e	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	f074240e-ef6b-45f2-8c4d-cb5c0dbc81f1	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	3686a2df-51c4-4f1c-9d1e-d69207915144	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	d0641def-425e-4357-a6b6-24ce00424549	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	dcf46d0c-87da-4009-b238-eb5cf287c3ed	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Golden State Medical Supply, Inc.	25b7276e-a69f-af63-e063-6394a90aecf2	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Biocon Pharma Inc.	9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	2f658680-939a-4212-8a5e-a44a896dd221	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	3b9fe7c9-791e-49a0-a005-ccf13036c365	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Northwind Health Company, LLC	40aa2d36-57ce-1f48-e063-6294a90affef	2026-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Northwind Health Company, LLC	47207487-0c6d-8da3-e063-6294a90a8aee	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	4ed7a4d1-1183-4d95-8311-6d3e58feafa8	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	Bryant Ranch Prepack	91c5b5c8-3379-4b84-aff7-ef6cfc65fe9f	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	33c141e9-76dc-4e32-9b2a-4621f32ac4bd	2025-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
Pravastatin sodium	PRAVASTATIN SODIUM	A-S Medication Solutions	72693449-01ee-42b0-9902-566252324579	2025-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	7b7f5c28-78fa-4625-ad69-4291500e033d	2025-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	51800012-406b-4389-817f-88dd21e338d1	2025-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	a7f75948-2958-44c8-b52f-5e39e80cdd1f	2025-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	e358f314-9cbe-46a4-9564-6bedc7ef9d59	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869 ndc (package): 63629-8910-1 ndc (product): 63629-8910 ndc11 (package): 63629891001
PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	80ddec55-6a18-4b87-8a07-6ae86ad62853	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209869 application number: ANDA209869

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	40 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
e358f314-9cbe-46a4-9564-6bedc7ef9d59	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	Strength	SPL version
63629-8910-1	PRAVASTATIN SODIUM	90 in 1 BOTTLE	TABLET	90		105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8910-1	EA - Each	63629-8910	721484f3-49a3-4701-aa1c-f7c2adaf0d49	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8910	PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]	105	Current NDC, Legacy NDC, 1 package rows	20250425_e358f314-9cbe-46a4-9564-6bedc7ef9d59.zip

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
904475	pravastatin sodium 40 MG Oral Tablet	PSN	e358f314-9cbe-46a4-9564-6bedc7ef9d59	105
904475	pravastatin sodium 40 MG Oral Tablet	SCD	e358f314-9cbe-46a4-9564-6bedc7ef9d59	105

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8910-1	63629891001	90 TABLET in 1 BOTTLE (63629-8910-1)	90 tablet	2021-11-19	0000-00-00	No	No	Current