Simvastatin

Product NDC: 72189-452
11-digit product format: 721890452
Labeler code: 72189
Product ID: 72189-452_2c4dc9a3-dd47-f0c9-e063-6294a90ad34d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Simvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA078103
Marketing category: ANDA
Marketing start: 2023-03-24
Substance: SIMVASTATIN
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-452-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-452-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-452-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-452-30	`0efc9e666f02…`	`f202fb6c5f17…`

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078103-001	SIMVASTATIN	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11
A078103-002	SIMVASTATIN	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11
A078103-003	SIMVASTATIN	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11
A078103-004	SIMVASTATIN	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11
A078103-005	SIMVASTATIN	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A078103-001	AB
A078103-002	AB
A078103-003	AB
A078103-004	AB
A078103-005	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 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-001	SIMVASTATIN	10MG	TABLET / ORAL	AB		2007-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-002	SIMVASTATIN	20MG	TABLET / ORAL	AB		2007-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-003	SIMVASTATIN	40MG	TABLET / ORAL	AB		2007-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	RS	2007-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-005	SIMVASTATIN	5MG	TABLET / ORAL	AB		2009-04-14	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 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	A078103-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078103-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078103-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078103-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078103-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078103-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078103-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078103-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078103-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078103-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078103-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078103-005	AB	1	`03ed91905a0d…`

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: Simvastatin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SIMVASTATIN	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
AGG2FN16EV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
314231	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
f7aa095f-590c-98e3-e053-6394a90ad972	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5347abc9-d72b-9efb-f582-cc87efafcf1b	Product name	4	20250729
c4422d73-8e69-1539-606a-32a25fa00ebc	Product name	4	20190926
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6	Product name	1	20160615
0a5e5249-329b-0cff-e714-77159f193a87	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-452-30	Simvastatin	30 in 1 BOTTLE	TABLET, FILM COATED	30		2
72189-452-90	Simvastatin	90 in 1 BOTTLE	TABLET, FILM COATED	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-452-30	EA - Each	72189-452	eedf63b5-f7a8-4bf5-8177-0ec3797bd223	1	2023-04-07
72189-452-90	EA - Each	72189-452	32b150c2-1ce0-4206-8d93-c94a5e6f3d8c	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-452	SIMVASTATIN TABLET, FILM COATED [DIRECT_RX]	2	Current NDC, 2 package rows	20250123_f7aa095f-590c-98e3-e053-6394a90ad972.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 3 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simvastatin	SIMVASTATIN	Direct_Rx	f7aa095f-590c-98e3-e053-6394a90ad972	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103 ndc (product): 72189-452
SIMVASTATIN	SIMVASTATIN	NCS HealthCare of KY, LLC dba Vangard Labs	1ddc0230-24ab-4e69-9c6c-6776c354c82c	2024-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	Proficient Rx LP	dad0dd7d-3049-4be4-aaeb-8a1895d55208	2023-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	NCS HealthCare of KY, LLC dba Vangard Labs	8850724a-a431-46e5-b88e-1d77b0b62d6e	2022-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103
SIMVASTATIN	SIMVASTATIN	Proficient Rx LP	7649bec7-04c6-47b5-a050-15923006dac0	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078103 application number: ANDA078103

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
AGG2FN16EV	SIMVASTATIN	79902-63-9	SIMVASTATIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314231	simvastatin 10 MG Oral Tablet	PSN	f7aa095f-590c-98e3-e053-6394a90ad972	2
314231	simvastatin 10 MG Oral Tablet	SCD	f7aa095f-590c-98e3-e053-6394a90ad972	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72189-452-30	72189045230	30 TABLET, FILM COATED in 1 BOTTLE (72189-452-30)	2023-03-24	No	No	Current
72189-452-90	72189045290	90 TABLET, FILM COATED in 1 BOTTLE (72189-452-90)	2023-03-24	No	No	Current