simvastatin

Product NDC: 16729-007
11-digit product format: 167290007
Labeler code: 16729
Product ID: 16729-007_43910ff2-6a21-bf9e-e063-6294a90a3f5c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: simvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Accord Healthcare, Inc.
Application: ANDA078155
Marketing category: ANDA
Marketing start: 2008-02-26
Substance: SIMVASTATIN
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

Additional Listing Data#

Finished product: Yes
Brand name base: simvastatin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SIMVASTATIN	80 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	AGG2FN16EV
Rxcui	198211, 200345, 312961, 312962, 314231

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
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
16729-007-10	simvastatin	30 in 1 BOTTLE	TABLET, FILM COATED	30	22
16729-007-12	simvastatin	60 in 1 BOTTLE	TABLET, FILM COATED	60	22
16729-007-15	simvastatin	90 in 1 BOTTLE	TABLET, FILM COATED	90	22
16729-007-17	simvastatin	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-007-10	EA - Each	16729-007	1b1ce1d0-6e7f-4d61-901d-185d0ec9879c	1	2012-07-24
16729-007-15	EA - Each	16729-007	737a754d-104a-48ae-ba71-e216695d38a0	1	2012-07-24
16729-007-17	EA - Each	16729-007	3dedd556-4c72-4ed0-a70f-11a8c84d6d83	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 [ACCORD HEALTHCARE, INC.]	13
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-007	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	21	Current NDC, Legacy NDC, 4 package rows	20240719_871251c0-36a1-4a32-9eab-ff6c1e925ca9.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
200345	simvastatin 80 MG Oral Tablet	PSN	c6b610ab-7367-4e61-9b4a-7ebbd1cf3d36	26
200345	simvastatin 80 MG Oral Tablet	SCD	c6b610ab-7367-4e61-9b4a-7ebbd1cf3d36	26
314231	simvastatin 10 MG Oral Tablet	PSN	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
312961	simvastatin 20 MG Oral Tablet	PSN	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
198211	simvastatin 40 MG Oral Tablet	PSN	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
312962	simvastatin 5 MG Oral Tablet	PSN	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
200345	simvastatin 80 MG Oral Tablet	PSN	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
314231	simvastatin 10 MG Oral Tablet	SCD	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
312961	simvastatin 20 MG Oral Tablet	SCD	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
198211	simvastatin 40 MG Oral Tablet	SCD	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
312962	simvastatin 5 MG Oral Tablet	SCD	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
200345	simvastatin 80 MG Oral Tablet	SCD	871251c0-36a1-4a32-9eab-ff6c1e925ca9	22
200345	simvastatin 80 MG Oral Tablet	PSN	b6d5fb21-a1a8-53e5-80d9-dde0eede5ef5	11
200345	simvastatin 80 MG Oral Tablet	SCD	b6d5fb21-a1a8-53e5-80d9-dde0eede5ef5	11
200345	simvastatin 80 MG Oral Tablet	PSN	8a6972f4-f3d2-4024-93e9-bbed43784284	2
200345	simvastatin 80 MG Oral Tablet	SCD	8a6972f4-f3d2-4024-93e9-bbed43784284	2
314231	simvastatin 10 MG Oral Tablet	PSN	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
312961	simvastatin 20 MG Oral Tablet	PSN	8d63e5de-d89c-4d2a-970d-7d17f993b7fe	1
312961	simvastatin 20 MG Oral Tablet	PSN	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
198211	simvastatin 40 MG Oral Tablet	PSN	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
200345	simvastatin 80 MG Oral Tablet	PSN	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
200345	simvastatin 80 MG Oral Tablet	PSN	8d63e5de-d89c-4d2a-970d-7d17f993b7fe	1
314231	simvastatin 10 MG Oral Tablet	SCD	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
312961	simvastatin 20 MG Oral Tablet	SCD	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
312961	simvastatin 20 MG Oral Tablet	SCD	8d63e5de-d89c-4d2a-970d-7d17f993b7fe	1
198211	simvastatin 40 MG Oral Tablet	SCD	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
200345	simvastatin 80 MG Oral Tablet	SCD	330e35ed-fd6b-4123-864a-a5aa339c24d6	1
200345	simvastatin 80 MG Oral Tablet	SCD	8d63e5de-d89c-4d2a-970d-7d17f993b7fe	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-007-10	16729000710	30 TABLET, FILM COATED in 1 BOTTLE (16729-007-10)	2008-02-26	0000-00-00	No	No	Current
16729-007-12	16729000712	60 in 1 BOTTLE					Historical
16729-007-15	16729000715	90 TABLET, FILM COATED in 1 BOTTLE (16729-007-15)	2008-02-26	0000-00-00	No	No	Current
16729-007-17	16729000717	1000 TABLET, FILM COATED in 1 BOTTLE (16729-007-17)	2008-02-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
simvastatin	PD-Rx Pharmaceuticals, Inc.	2026-05-12	HUMAN PRESCRIPTION DRUG LABEL	26
simvastatin	Accord Healthcare, Inc. \| Intas Pharmaceuticals Limited.	2025-11-14	HUMAN PRESCRIPTION DRUG LABEL	22
simvastatin	Bryant Ranch Prepack	2024-08-08	HUMAN PRESCRIPTION DRUG LABEL	11
simvastatin	Aphena Pharma Solutions - Tennessee, LLC	2019-12-19	HUMAN PRESCRIPTION DRUG LABEL	2
simvastatin	Blenheim Pharmacal, Inc.	2015-11-25	HUMAN PRESCRIPTION DRUG LABEL	1
simvastatin	Rebel Distributors Corp	2011-12-27	HUMAN PRESCRIPTION DRUG LABEL	1

simvastatin

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#