NDC 0517-0785-01 - Benztropine Mesylate
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
- 0517-0785
- Requested NDC
- 0517-0785-01
- Package NDCs from labels
- 0517-0785-01, 0517-0785-05
- Manufacturer
- American Regent, Inc.
- Effective date
- 2011-05-10
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Benztropine Mesylate Injection, USP | American Regent, Inc. | 2011-05-10 | HUMAN PRESCRIPTION DRUG LABEL |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0517-0785-05 | 2019-12-04 | C162847 | 48780-1 | 960f7f55-d8ad-8e05-e053-dbdaa90a074a | Benztropine Mesylate Injection, USP |
| 0517-0785-05 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d8ad-8e05-e053-dbdaa90a074a | Benztropine Mesylate Injection, USP |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0517-0785-05 | ML - Milliliter | 0517-0785 | 3378fb4c-9f3a-42a7-b1b0-ef6803f53553 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BENZTROPINE MESYLATE | ACTIVE INGREDIENT | WMJ8TL7510 | BENZTROPINE MESYLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 1 | |
| BENZTROPINE | ACTIVE MOIETY | 1NHL2J4X8K | BENZTROPINE MESYLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | BENZTROPINE MESYLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BENZTROPINE MESYLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 1 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cold and Cough | ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEAL | Wal-Mart Stores, Inc. | 69349b4d-6c5b-7121-e053-2991aa0a3594 | 2022-12-15 | Warnings | 451W47IQ8X |
| Childrens Cold and Cough Nighttime | ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEAL | Walgreen Company | 80c41b65-0411-4395-e053-2a91aa0a9df9 | 2022-12-15 | Warnings | 451W47IQ8X |
| Childrens Cold and Cough | ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEAL | Walgreen Company | 80b5f707-a839-7729-e053-2991aa0a1c56 | 2022-12-15 | Warnings | 451W47IQ8X |
| FERRODONNA | ARSENIC TRIOXIDE, CEANOTHUS AMERICANUS LEAF, CINCHONA OFFICINALIS BARK, COBALTOUS NITRATE, CUPRIC SULFATE, IRON, MANGANESE ACETATE, AND SODIUM CHLORIDE | PEKANA Naturheilmittel GmbH | 64c6f75a-382d-4aa0-b210-6be83a62fa3f | 2022-12-14 | Warnings | 451W47IQ8X |
| Nat Mur | SODIUM CHLORIDE | Hyland's Inc. | d3ab4254-daaf-24ac-e053-2995a90afb8f | 2022-12-13 | Warnings | 451W47IQ8X |
| Rest | SILVER NITRATE,CAUSTICUM,MATRICARIA CHAMOMILLA,ANAMIRTA COCCULUS SEED,SODIUM CHLORIDE,PHOSPHORUS AND VALERIAN | Hyland's Inc. | 5e9924be-4dad-324a-e053-2a91aa0a8ec1 | 2022-12-13 | Warnings | 451W47IQ8X |
| Defend Cold and Mucus | BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PATENS, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE | Hyland's Inc. | bb851be1-0528-4199-91e7-e09f994b2862 | 2022-12-12 | Warnings | 451W47IQ8X |
| BACTERIOSTATIC SODIUM CHLORIDE | BACTERIOSTATIC SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 7611e508-6da2-3a2f-e053-2a91aa0a9f40 | 2022-12-09 | Boxed warning, Warnings, Adverse reactions | 451W47IQ8X |
| BACTERIOSTATIC SODIUM CHLORIDE | BACTERIOSTATIC SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 763ff805-af1a-e8e9-e053-2a91aa0a8253 | 2022-12-09 | Boxed warning, Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | 2fae04e3-20b1-4b8c-b1fb-646b384836f1 | 2022-12-07 | Warnings, Adverse reactions | 451W47IQ8X |
| MET TOX | ARSENICUM ALB, AVENA, BERBERIS VULG, LYCOPODIUM, NAT MUR, NUX VOM, PHYTOLACCA, RHAMNUS FRANG, SOLIDAGO, TRIFOLIUM PRAT | White Manufacturing Inc. DBA Micro-West | 2653d62b-5dd7-482c-b31c-ce5fa1373900 | 2022-12-02 | Warnings | 451W47IQ8X |
| Miranda Castros Healing Gel for Bites and Stings | CALENDULA OFFICINALIS, CALADIUM SEGUINUM, LEDUM PALUSTRE, NATRUM MURIATICUM, PLANTAGO MAJOR, STAPHYSAGRIA, URTICA URENS. | OHM PHARMA INC. | 8e06aaa4-c177-45cf-9d8d-e0099de25668 | 2022-12-02 | Warnings | 451W47IQ8X |
| Yonis Bliss | CHAMOMILLA, NATRUM MURIATICUM | Brookhaus Essentials LLC | ea4091d6-d295-41a0-aae5-68f3c260e110 | 2022-11-30 | Warnings | 451W47IQ8X |
| 4 Kids Cold and Mucus Nighttime | EUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFUR | Hyland's Inc. | 6f7b2585-2f0e-5938-e053-2a91aa0aa9d1 | 2022-11-21 | Warnings | 451W47IQ8X |
| 4 Kids Complete Cold and Mucus | BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE | Hyland's Inc. | ef39fe3d-a42d-4baa-9199-91f664feb432 | 2022-11-21 | Warnings | 451W47IQ8X |
| Multiple Electrolytes pH 7.4 | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE | Fresenius Kabi USA, LLC | 84221110-b3f1-42f4-800c-ad1d3b330e9e | 2022-11-10 | Warnings, Adverse reactions | 451W47IQ8X |
| Multiple Electrolytes pH 5.5 | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE | Fresenius Kabi USA, LLC | cf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c | 2022-11-10 | Warnings, Adverse reactions | 451W47IQ8X |
| Natrum Muriaticum | NATRUM MURIATICUM | Hahnemann Laboratories, INC. | ecf06f13-012c-212d-e053-2995a90a7198 | 2022-11-08 | 451W47IQ8X | |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | b45e9f1d-9c48-4b46-8541-d846b89540df | 2022-10-26 | Warnings, Adverse reactions | 059QF0KO0R |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 51da05ce-e3c4-4ef5-a845-dc869152e17f | 2022-10-24 | Warnings, Adverse reactions | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.