Biopar delta-FORTE

Product NDC: 64661-793
11-digit product format: 646610793
Labeler code: 64661
Product ID: 64661-793_323865ea-64df-4d83-bc35-b0913b63b43f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: 1 NF Units, 50 mcg CBl, 2.5 mg F-THf, 1 mg PteGlu-, 7 mg Me-THf
Dosage form: CAPSULE
Route: ORAL
Labeler: Jaymac Pharmacueticals LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2022-06-24
Marketing end: 0000-00-00
Substance: COBALAMIN; COBAMAMIDE; DIHYDROFOLIC ACID; INTRINSIC FACTOR; LEVOLEUCOVORIN; LEVOMEFOLATE MAGNESIUM
Active strength: 50 ug/1; ug/1; mg/1; mg/1; mg/1; mg/1
Pharmacologic classes: Folate Analog [EPC], Folic Acid [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64661-793		D	Discontinued by firm	2026-10-20
excluded product	product	64661-793		I	Inactivated by FDA	2026-10-20
excluded package	package	64661-793	64661-793-30	D	Discontinued by firm	2026-10-20

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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1c9d1af-bddd-448d-86f7-69052b7d5b47	Product name	1	20220627
91c62db0-0295-c81c-d10a-0856c259edd6	Product name	2	20200428
d5f7850a-bc65-4866-8340-2b197ae4d8ca	Product name	9	20200206
d32bc2b8-0bb7-2216-87aa-24639646e202	Product name	3	20190619
2642c4da-5f9c-4531-8406-dc7d1c3a9032	Product name	1	20190201
ddff2484-d547-4e6a-bacd-95eef7e31c64	Product name	2	20180807
90854981-3820-4bc4-a1d3-666ec508941c	Product name	2	20180214
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64661-793-30	Biopar delta-FORTE	1 in 1 BLISTER PACK	CAPSULE	1		14
64661-793-30	Biopar delta-FORTE	30 in 1 CARTON	CAPSULE	30		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64661-793-30	EA - Each	64661-793	196bfbb3-d0fe-43f6-86da-f8ec6590a362	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64661-793	BIOPAR DELTA-FORTE (1 NF UNITS, 50 MCG CBL, 2.5 MG F-THF, 1 MG PTEGLU-, 7 MG ME-THF) CAPSULE [JAYMAC PHARMA]	13	Legacy NDC, 2 package rows	20240717_ce7d1f45-0e38-48c5-abf6-b229c6b2e9b3.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8406EY2OQA	COBALAMIN	13408-78-1	COBALAMIN
F0R1QK73KB	COBAMAMIDE	13870-90-1	COBAMAMIDE
KXP0KNM559	DIHYDROFOLIC ACID	4033-27-6	DIHYDROFOLIC ACID
70BT6OQT2Q	INTRINSIC FACTOR	9008-12-2	INTRINSIC FACTOR
990S25980Y	LEVOLEUCOVORIN	68538-85-2	LEVOLEUCOVORIN
1VZZ62R081	LEVOMEFOLATE MAGNESIUM	1429498-11-2	LEVOMEFOLATE MAGNESIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64661-793-30	64661079330	30 BLISTER PACK in 1 CARTON (64661-793-30) > 1 CAPSULE in 1 BLISTER PACK	30 blister pack	2022-06-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Biopar TM delta -FORTE	Jaymac Pharma \| Viva Pharmaceuticals INC	2025-12-08	HUMAN PRESCRIPTION DRUG LABEL	14