NDC 70710-1365-2 - Emtricitabine and tenofovir disoproxil fumarate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 70710-1365
Requested NDC: 70710-1365-2
Package NDCs from labels: 70710-1365-3, 70710-1365-2, 70710-1365-4, 70710-1365-9
Manufacturer: Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited
Effective date: 2024-05-10
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
EMTRICITABINE - Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2024-05-10	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70710-1365-2	Emtricitabine and tenofovir disoproxil fumarate	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	8
70710-1365-3	Emtricitabine and tenofovir disoproxil fumarate	30 in 1 BOTTLE	TABLET, FILM COATED	30	8
70710-1365-4	Emtricitabine and tenofovir disoproxil fumarate	10 in 1 CARTON	TABLET, FILM COATED	10	8
70710-1365-9	Emtricitabine and tenofovir disoproxil fumarate	90 in 1 BOTTLE	TABLET, FILM COATED	90	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70710-1365	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]	8	Current NDC, Legacy NDC, 4 package rows	20240518_7def7a95-e69e-4985-974a-efacadcecc95.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70710-1365-3	EA - Each	70710-1365	0ad390b6-b292-4401-a209-b7d2c10e0f33	1	2021-08-05

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 106 of 108 · 2,144 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Cameo	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	01a861b9-0ab6-4c4c-a407-428a64509a1c	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Birch	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	d5431d62-fded-4cdc-81a1-5b5e3eb92873	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Tawny	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	52c3378f-6b99-42fa-900e-8a693864c615	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Exelan Pharmaceuticals, Inc.	31af598d-6ef2-469b-ac4c-3ac805e6fa44	2021-04-06	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 476556 unii: OTT9J7900I unii: G70B4ETF4S
efavirenz, emtricitabine and tenofovir disoproxil fumarate	EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Cipla USA Inc.	a7d94a1c-31b0-4272-8f8d-186d580e16e0	2021-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: OTT9J7900I unii: G70B4ETF4S
CIMDUO	LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	Viatris Specialty LLC	a300f04d-118f-4136-aaf3-ddfd00197f86	2021-02-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: OTT9J7900I
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Cipla USA Inc.	1ac2a796-495e-4182-8eec-40363d8a85c0	2021-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 476556 unii: OTT9J7900I unii: G70B4ETF4S
Emtricitabine and Tenofovir Disoproxil Fumarate	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Amneal Pharmaceuticals NY LLC	b0459301-2bff-4336-9172-b90c7a582433	2020-11-29	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1744009 rxcui: 476556 rxcui: 1744001 rxcui: 1744005 unii: OTT9J7900I unii: G70B4ETF4S
SYMFI	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	Viatris Specialty LLC	81a55dd9-78a8-49c3-88ab-8f5bffafa359	2019-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: OTT9J7900I
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool Vanilla	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	d701c221-9f68-47ff-b766-2f4f1998649f	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Amber	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	7f5e6872-4d26-410e-8afe-16a016f9a399	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Advanced All in One Foundation SPF 50 Warm Ivory	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	1124ba7d-a328-409b-8c88-e74bb3e501f5	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Advanced All in One Foundation SPF 50 Honey	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	9c407dc7-fcde-4660-9a06-57bd8a6b867d	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Chestnut	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	f07e8bb2-30ae-4337-ad60-84f55f2ff354	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
Tenofovir Disoproxil Fumarate	TENOFOVIR DISOPROXIL FUMARATE	NorthStar RxLLC	eaeb1670-4e39-4541-8ff7-47057f3f5c36	2018-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: OTT9J7900I
CLE CCC Golden Medium Deep	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	b7a4847f-b84d-4f36-8787-104eccd838a0	2018-12-03	Warnings	Exact identifier unii: 15FIX9V2JP
CLE CCC Warm Medium Deep	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	229c20a3-6288-4ac3-9098-6d1622e906ab	2018-11-29	Warnings	Exact identifier unii: 15FIX9V2JP
CLE CCC Warm Medium Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	fc90fb8a-44b3-47cd-882e-94ed324ed389	2018-11-27	Warnings	Exact identifier unii: 15FIX9V2JP
CLE CCC Warm Medium	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	b585f216-4234-47c5-9a6b-8b133ef48aae	2018-11-27	Warnings	Exact identifier unii: 15FIX9V2JP
CLE CCC Warm Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	14891e26-b3b6-4545-99b1-da914b7f5629	2018-11-24	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.