Simvastatin

Product NDC: 72865-307
Requested package NDC: 72865-307-10
11-digit product format: 728650307
Labeler code: 72865
Product ID: 72865-307_48bd010d-6429-906e-e063-6394a90ae8b7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Simvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: XLCare Pharmaceuticals Inc.
Application: ANDA200895
Marketing category: ANDA
Marketing start: 2026-01-21
Substance: SIMVASTATIN
Active strength: 20 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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	Approval date
A200895-001	SIMVASTATIN	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25
A200895-002	SIMVASTATIN	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25
A200895-003	SIMVASTATIN	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25
A200895-004	SIMVASTATIN	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25
A200895-005	SIMVASTATIN	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200895-001	AB
A200895-002	AB
A200895-003	AB
A200895-004	AB
A200895-005	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-001	SIMVASTATIN	5MG	TABLET / ORAL	AB	2014-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-002	SIMVASTATIN	10MG	TABLET / ORAL	AB	2014-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-003	SIMVASTATIN	20MG	TABLET / ORAL	AB	2014-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-004	SIMVASTATIN	40MG	TABLET / ORAL	AB	2014-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-005	SIMVASTATIN	80MG	TABLET / ORAL	AB	2014-11-25	`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	A200895-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200895-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200895-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200895-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200895-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200895-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200895-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200895-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200895-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200895-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200895-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200895-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200895-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200895-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200895-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200895-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200895-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200895-005	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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SIMVASTATIN	20 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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198211	Internal RxNorm lookup
200345	Internal RxNorm lookup
312961	Internal RxNorm lookup
312962	Internal RxNorm lookup
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
433f8a86-5ad3-43db-8e62-c0812dd3d723	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
c4422d73-8e69-1539-606a-32a25fa00ebc	Product name	4	20190926
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
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	SPL version
72865-307-01	Simvastatin	100 in 1 BOTTLE	TABLET, FILM COATED	100	1
72865-307-10	Simvastatin	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	1
72865-307-30	Simvastatin	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
72865-307-45	Simvastatin	45 in 1 BOTTLE	TABLET, FILM COATED	45	1
72865-307-90	Simvastatin	90 in 1 BOTTLE	TABLET, FILM COATED	90	1

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simvastatin	SIMVASTATIN	XLCare Pharmaceuticals Inc.	433f8a86-5ad3-43db-8e62-c0812dd3d723	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200895 application number: ANDA200895 ndc (package): 72865-307-10 ndc (product): 72865-307 ndc11 (package): 72865030710
Simvastatin	SIMVASTATIN	Quallent Pharmaceuticals Health LLC	2b4255a7-f9f5-4235-8dbb-b0f03acbd624	2024-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200895 application number: ANDA200895
Simvastatin	SIMVASTATIN	Camber Pharmaceuticals, Inc.	751b79c6-bba8-4d29-b69c-a2ac6453fec8	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200895 application number: ANDA200895

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	433f8a86-5ad3-43db-8e62-c0812dd3d723	1
312961	simvastatin 20 MG Oral Tablet	PSN	433f8a86-5ad3-43db-8e62-c0812dd3d723	1
198211	simvastatin 40 MG Oral Tablet	PSN	433f8a86-5ad3-43db-8e62-c0812dd3d723	1
312962	simvastatin 5 MG Oral Tablet	PSN	433f8a86-5ad3-43db-8e62-c0812dd3d723	1
200345	simvastatin 80 MG Oral Tablet	PSN	433f8a86-5ad3-43db-8e62-c0812dd3d723	1
314231	simvastatin 10 MG Oral Tablet	SCD	433f8a86-5ad3-43db-8e62-c0812dd3d723	1
312961	simvastatin 20 MG Oral Tablet	SCD	433f8a86-5ad3-43db-8e62-c0812dd3d723	1
198211	simvastatin 40 MG Oral Tablet	SCD	433f8a86-5ad3-43db-8e62-c0812dd3d723	1
312962	simvastatin 5 MG Oral Tablet	SCD	433f8a86-5ad3-43db-8e62-c0812dd3d723	1
200345	simvastatin 80 MG Oral Tablet	SCD	433f8a86-5ad3-43db-8e62-c0812dd3d723	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72865-307-10	72865030710	1000 TABLET, FILM COATED in 1 BOTTLE (72865-307-10)	2026-01-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Simvastatin	XLCare Pharmaceuticals Inc. \| Evaric Pharmaceuticals Inc	2026-01-19	HUMAN PRESCRIPTION DRUG LABEL	1