Vitafol OB
- Product NDC
- 0642-0079
- Requested package NDC
- 0642-0079-03
- 11-digit product format
- 006420079
- Labeler code
- 0642
- Product ID
- 0642-0079_f12aec60-46b4-6b23-e053-2995a90acb08
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vitamin A, Ascorbic Acid, Vitamin D, .Alpha.-Tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, Iron, Magnesium, Zinc, and Copper
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Exeltis USA, Inc.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2002-12-02
- Marketing end
- 0000-00-00
- Substance
- .ALPHA.-TOCOPHEROL; ASCORBIC ACID; CALCIUM; COPPER; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A; VITAMIN D; ZINC
- Active strength
- 30 [iU]/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1
- Pharmacologic classes
- Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calcium [CS], Calcium [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0642-0079 | 0642-0079-03 | I | Inactivated by FDA | 2026-10-05 |
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.
| Captured / source date | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c599c4a0-705d-4ebb-ab1f-977af038f96a | Product name | 1 | 20251124 |
| cf050ccd-1144-f76a-e00d-e5698d8597d4 | Product name | 6 | 20250625 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| b82b4008-22fd-05f5-6cc6-c0a6e81c65b8 | Product name | 2 | 20240805 |
| 910c1bd7-67d1-44c7-ad4f-9445f827edcc | Product name | 1 | 20230808 |
| 91c62db0-0295-c81c-d10a-0856c259edd6 | Product name | 2 | 20200428 |
| d32bc2b8-0bb7-2216-87aa-24639646e202 | Product name | 3 | 20190619 |
| e2dae634-14ed-febf-08ee-93196433b5b7 | Product name | 9 | 20190614 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| d206bb34-ea65-399d-70d9-834f22dc2c18 | Product name | 3 | 20170724 |
| 5e18e798-5614-cf5c-0185-38b1cb77a093 | Product name | 2 | 20160822 |
| 0a5e5249-329b-0cff-e714-77159f193a87 | Product name | 1 | 20140508 |
| 60c52429-fcef-eb54-2387-43bc9e4f296b | Product name | 1 | 20140508 |
| 6b7a6f32-42a6-994d-5ab6-d180e92ee9d8 | Product name | 1 | 20140508 |
| d394f843-7479-dc48-dbd3-232266c5548c | Product name | 1 | 20140508 |
| dc9a5fb6-14e2-1cc8-a567-a781fd1f0212 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 0642-0079-03 | 2025-01-30 | Vitafol ® -OB Prenatal Supplement |
| 0642-0079-12 | 2025-01-30 | Vitafol ® -OB Prenatal Supplement |
| 0642-0079-08 | 2022-12-31 | Vitafol ® -OB Prenatal Supplement |
| 0642-0079-12 | 2022-12-31 | Vitafol ® -OB Prenatal Supplement |
| 0642-0079-08 | 2022-07-29 | Vitafol ® -OB Prenatal Supplement |
| 0642-0079-12 | 2022-07-29 | Vitafol ® -OB Prenatal Supplement |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0642-0079-03 | Vitafol OBCaplet | 3 in 1 CARTON | TABLET | 3 | 6 | |
| 0642-0079-12 | Vitafol OBCaplet | 100 in 1 CARTON | TABLET | 100 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0642-0079-12 | EA - Each | 0642-0079 | dc42a2ac-4a5b-4805-a23e-2d1a39417997 | 1 | 2014-10-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0642-0079 | VITAFOL OB CAPLET (VITAMIN A, ASCORBIC ACID, VITAMIN D, .ALPHA.-TOCOPHEROL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, IRON, MAGNESIUM, ZINC, AND COPPER) TABLET [EXELTIS USA, INC.] | 6 | Legacy NDC, 2 package rows | 20230102_22828f24-600d-4aa6-9b3a-cf8c991f9a97.zip |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0642-0079-03 | 00642007903 | 3 TABLET in 1 CARTON (0642-0079-03) | 3 tablet | 2015-11-09 | 0000-00-00 | Yes | No | Current |