Simvastatin

Product NDC: 55111-200
Requested package NDC: 55111-200-01
11-digit product format: 551110200
Labeler code: 55111
Product ID: 55111-200_84334c5d-1663-972c-5d96-03eb1be16f64
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Simvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Dr. Reddy's Laboratories Limited
Application: ANDA077752
Marketing category: ANDA
Marketing start: 2006-12-20
Marketing end: 0000-00-00
Substance: SIMVASTATIN
Active strength: 40 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55111-200	55111-200-01	D	Discontinued by firm		2026-08-17

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
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55111-200	55111-200-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55111-200	55111-200-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077752-001	SIMVASTATIN	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20
A077752-002	SIMVASTATIN	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20
A077752-003	SIMVASTATIN	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20
A077752-004	SIMVASTATIN	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20
A077752-005	SIMVASTATIN	SIMVASTATIN	5MG	TABLET / ORAL	AB	2008-01-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077752-001	AB
A077752-002	AB
A077752-003	AB
A077752-004	AB
A077752-005	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 · 210 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
2026-08-18 06:07:40	2026-07	A077752-001	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077752-002	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077752-003	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077752-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077752-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2008-01-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077752-001	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077752-002	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077752-003	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077752-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077752-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2008-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077752-001	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077752-002	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077752-003	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077752-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077752-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2008-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077752-001	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077752-002	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077752-003	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077752-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077752-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2008-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077752-001	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077752-002	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077752-003	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077752-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077752-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2008-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077752-001	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077752-002	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077752-003	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077752-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077752-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2008-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077752-001	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077752-002	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077752-003	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077752-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077752-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2008-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077752-001	SIMVASTATIN	10MG	TABLET / ORAL	AB	2006-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077752-002	SIMVASTATIN	20MG	TABLET / ORAL	AB	2006-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077752-003	SIMVASTATIN	40MG	TABLET / ORAL	AB	2006-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077752-004	SIMVASTATIN	80MG	TABLET / ORAL	AB	2006-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077752-005	SIMVASTATIN	5MG	TABLET / ORAL	AB	2008-01-23	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077752-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077752-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077752-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077752-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077752-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077752-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077752-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077752-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077752-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077752-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077752-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077752-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077752-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077752-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077752-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077752-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077752-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077752-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077752-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077752-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077752-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077752-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077752-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077752-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077752-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077752-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077752-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077752-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077752-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077752-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077752-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077752-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077752-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077752-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077752-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077752-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077752-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077752-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077752-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077752-005	AB	1	`2680178bc6a6…`

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
c4422d73-8e69-1539-606a-32a25fa00ebc	Product name	4	20190926
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6	Product name	1	20160615
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
0a5e5249-329b-0cff-e714-77159f193a87	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55111-200-05	EA - Each	55111-200	b047bd64-baf8-4aa0-9990-90069703a3a2	1	2012-07-24
55111-200-10	EA - Each	55111-200	7219ef7a-6fe8-4817-a4d1-bf9214dbbc20	1	2012-07-24
55111-200-30	EA - Each	55111-200	df0468d4-5307-4a7c-b305-3d6ef3e4bad4	1	2012-07-24
55111-200-90	EA - Each	55111-200	d18a95ce-b62b-4895-b75d-fc4b9ff89f33	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Simvastatin	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]	9
Simvastatin	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]	9
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]	9
ascorbic acid	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]	9
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]	9
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]	9
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]	9
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]	9
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]	9
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]	9
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]	9
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]	9
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]	9
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]	9
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]	8
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]	8
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	SIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]	8
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]	8
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]	8
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]	8
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	SIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]	8
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]	8
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	SIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET [LEGACY PHARMACEUTICAL PACKAGING]	8
Simvastatin	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]	1
Simvastatin	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
Simvastatin	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]	1
Simvastatin	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	SIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
ascorbic acid	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]	1
ascorbic acid	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	SIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]	1
hypromellose	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]	1
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	SIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55111-200	SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]	14	Legacy NDC	20190312_d9a1a7c5-d806-4dbd-a201-5e73790d078b.zip

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
312961	simvastatin 20 MG Oral Tablet	PSN	e9e50cdb-4cef-4d03-9fb6-973d0c2bf293	8
198211	simvastatin 40 MG Oral Tablet	PSN	e9e50cdb-4cef-4d03-9fb6-973d0c2bf293	8
312961	simvastatin 20 MG Oral Tablet	SCD	e9e50cdb-4cef-4d03-9fb6-973d0c2bf293	8
198211	simvastatin 40 MG Oral Tablet	SCD	e9e50cdb-4cef-4d03-9fb6-973d0c2bf293	8
198211	simvastatin 40 MG Oral Tablet	PSN	6e030b0f-8ee6-4b23-9345-7193d4280e88	1
198211	simvastatin 40 MG Oral Tablet	SCD	6e030b0f-8ee6-4b23-9345-7193d4280e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55111-200-01	55111020001	100 TABLET, FILM COATED in 1 BOTTLE (55111-200-01)	2006-12-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Simvastatin	Dr. Reddy's Laboratories Limited \| Dr.Reddy's Laboratories Limited	2018-12-06	HUMAN PRESCRIPTION DRUG LABEL	14
Simvastatin	Life Line Home Care Services, Inc.	2012-03-12	HUMAN PRESCRIPTION DRUG LABEL	1
Simvastatin	Legacy Pharmaceutical Packaging	2011-12-13	HUMAN PRESCRIPTION DRUG LABEL	8
Simvastatin	NCS HealthCare of KY, Inc dba Vangard Labs	2011-11-30	HUMAN PRESCRIPTION DRUG LABEL	8
Simvastatin	Contract Pharmacy Services-PA	2010-06-17	HUMAN PRESCRIPTION DRUG LABEL	1