Dactinomycin for injection is indicated for the treatment of adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen. Dactinomycin for injection is indicated for the treatment of adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen. Dactinomycin for injection is indicated for the treatment of adult and pedia...
The recommended dose of dactinomycin for injection, as part of a multi-agent combination chemotherapy regimen, is 45 mcg/kg intravenously once every 3 to 6 weeks for up to 26 weeks. The recommended dose of dactinomycin for injection, as part of a multi-agent combination chemotherapy regimen, is 15 mcg/kg intravenously once daily for 5 days every 3 to 9 weeks for up to112 weeks. The recommended dose of dactinomycin...
Dactinomycin for injection, USP is a lyophilized powder. In the dry form the compound is an amorphous yellow to orange powder. The solution is clear, gold or yellow to orange colored and essentially free from visible particles. Dactinomycin for injection, USP is supplied in vials containing 0.5 mg (500 micrograms) of dactinomycin and 20.0 mg of mannitol. NDC 67457-513-05 : 0.5 mg/vial in 2 mL single-dose vial; ind...
www.fda.gov/medwatch
www.osha.gov/SLTC/hazardousdrugs/index.htmlDactinomycin for injection is indicated for the treatment of adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen.
Dactinomycin for injection is indicated for the treatment of adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen.
Dactinomycin for injection is indicated for the treatment of adult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen.
Dactinomycin for injection is indicated for the treatment of adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen.
Dactinomycin for injection is indicated for the treatment of post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen.
Dactinomycin for injection is indicated for the treatment of adult patients with locally recurrent or locoregional solid malignancies, as a component of palliative or adjunctive regional perfusion.
The recommended dose of dactinomycin for injection, as part of a multi-agent combination chemotherapy regimen, is
45 mcg/kg intravenously once every 3 to 6 weeks for up to 26 weeks.
The recommended dose of dactinomycin for injection, as part of a multi-agent combination chemotherapy regimen, is 15 mcg/kg intravenously once daily for 5 days every 3 to 9 weeks for up to112 weeks.
The recommended dose of dactinomycin for injection, as part of a multi-agent combination chemotherapy regimen, is 1,250 mcg/m2 intravenously once every 3 weeks for 51 weeks.
The recommended dose of dactinomycin for injection, as part of a cisplatin-based, multi-agent combination chemotherapy regimen, is 1,000 mcg/m2 intravenously once every 3 weeks for 12 weeks.
The recommended dose of dactinomycin for injection for nonmetastatic and low-risk metastatic disease is 12 mcg/kg intravenously daily for five days as a single agent.
The recommended dose of dactinomycin for injection, as part of a multi-agent combination chemotherapy regimen, for high-risk metastatic disease is 500 mcg intravenously on Days 1 and 2 every 2 weeks for up to 8 weeks.
The recommended dose of dactinomycin for injection, in combination with melphalan, is 50 mcg/kg once for lower extremity or pelvis.
The recommended dose of dactinomycin for injection, in combination with melphalan, is 35 mcg/kg once for upper extremity.
Calculate the dose for obese or edematous patients based on ideal body weight.
Preparation
Administration
Management of Extravasation
For injection: 500 mcg as a sterile, amorphous yellow to orange, lyophilized powder in a single-dose vial.
None.
The risk of developing secondary malignancies, including leukemia, is increased following treatment with dactinomycin for injection.
Severe and fatal hepatic veno-occlusive disease (VOD) can occur with dactinomycin for injection. Risk factors for the development of VOD include age younger than 4 years or concomitant radiotherapy. After treatment with dactinomycin for injection, monitor frequently for signs and symptoms of VOD; these include elevations in AST, ALT, total bilirubin, hepatomegaly, weight gain, or ascites. If patients develop VOD, considering delaying next dose of dactinomycin for injection. Resume, reduce dose or permanently discontinue based on severity of reaction and disease being treated.
Extravasation of dactinomycin for injection can result in severe local tissue injury manifesting as blistering, ulcerations and persistent pain requiring wide excision surgery followed by split-thickness skin grafting. If any signs or symptoms of extravasation occur, immediately interrupt the injection or infusion. Apply ice to the site intermittently for 15 minutes, 4 times a day for 3 days [see Dosage and Administration (2.7) ]. Observe closely and consult plastic surgery if necessary based on severity of reaction.
Severe and fatal myelosuppression, which may include neutropenia, thrombocytopenia and anemia, can occur with dactinomycin for injection. The nadir in neutrophil counts generally occurs 14 to 21 days after administration. Obtain complete blood counts prior to each treatment cycle. Delay next dose of dactinomycin for injection if severe myelosuppression has not improved. Consider dose reduction for patients with prolonged myelosuppression based on severity of reaction and disease being treated.
The safety with live viral vaccines following dactinomycin for injection has not been studied and vaccination with live virus vaccines is not recommended before or during treatment.
Severe mucocutaneous reactions, such as Steven-Johnson syndrome and Toxic Epidermal Necrolysis (TEN), can occur with dactinomycin for injection. Permanently discontinue dactinomycin for injection in patients who experience a severe mucocutaneous reaction.
Abnormalities of renal function can occur with dactinomycin for injection. Monitor creatinine and electrolytes frequently during dactinomycin for injection therapy.
Hepatotoxicity can occur with dactinomycin for injection. Monitor AST, ALT, alkaline phosphatase, and bilirubin prior to and during dactinomycin for injection therapy.
Dactinomycin for injection can increase radiation-induced gastrointestinal toxicity, myelosuppression, or erythema and vesiculation of the skin or buccal and pharyngeal mucosa. Reduce the dose of dactinomycin for injection by 50% during concomitant radiation.
Radiation recall, affecting previously treated radiation fields, can occur in patients who receive dactinomycin for injection after prior radiation therapy. Although the risk can occur with distant radiation exposure, the risk appears highest when dactinomycin for injection is administered within two months of prior radiation.
Based on findings from animal studies and its mechanism of action, dactinomycin for injection can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of dactinomycin to pregnant animals during the period of organogenesis was teratogenic, resulting in malformations at doses lower than the recommended human dose.
Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with dactinomycin for injection and for at least 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with dactinomycin for injection and for 3 months after the final dose [see Use in Specific Populations (8.1, 8.3)].
The following serious adverse reactions are described elsewhere in the labeling:
Common adverse reactions are: infection, alopecia, rash, dysphagia, fatigue, fever, nausea, vomiting, anemia, neutropenia, thrombocytopenia, mucositis, and hepatotoxicity.
The following adverse reactions have been identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Infections: infections including sepsis with fatal outcome
Hematologic: anemia, leukopenia, thrombocytopenia, pancytopenia, reticulocytopenia, neutropenia, febrile neutropenia, disseminated intravascular coagulation
Immune system: hypersensitivity
Metabolism and nutrition: anorexia, hypocalcemia, tumor lysis syndrome
Nervous system: peripheral neuropathy
Ocular: optic neuropathy
Vascular: thrombophlebitis, hemorrhage
Respiratory, thoracic and mediastinal: pneumonitis, pneumothorax
Gastrointestinal: nausea, vomiting, abdominal pain, diarrhea, constipation, gastrointestinal ulceration, cheilitis, dysphagia, esophagitis, ulcerative stomatitis, ascites, proctitis, mucositis
Hepatobiliary: liver function test abnormalities, hepatomegaly, hepatitis, hepatic failure with reports of death, hepatic veno-occlusive disease
Dermatologic: alopecia, rash, dermatitis, acne, erythema multiforme, Stevens Johnson Syndrome, radiation recall, toxic epidermal necrolysis
Musculoskeletal and connective tissue: myalgia, growth retardation
Renal and urinary: renal impairment, renal failure
General: fatigue, fever, malaise
Risk Summary
Based on findings from animal studies and its mechanism of action dactinomycin for injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. In animal reproduction studies, administration of dactinomycin to pregnant animals during the period of organogenesis was teratogenic, resulting in malformations at doses lower than the recommended human dose (see Data). Advise pregnant women of the potential risk to a fetus [see Use in Special Populations (8.3)].
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data
Animal Data
Dactinomycin was teratogenic in animals. Administration of dactinomycin to pregnant rats, rabbits, and hamsters during the period of organogenesis, increased the incidence of fetal malformations and caused embryotoxicity at doses (based on body surface area) as low as 0.2 times the clinical dose of 1,250 mcg/m2.
Risk Summary
There are no data on the presence of dactinomycin or its metabolites in human milk or their effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in breastfed infants from dactinomycin for injection, advise women not to breastfeed during treatment with dactinomycin for injection and, based on limited published data regarding the dactinomycin half-life, for 14 days after the final dose.
Pregnancy Testing
Verify the pregnancy status of females of reproductive potential prior to initiating dactinomycin for injection[see Use in Specific Population (8.1)].
Contraception
Dactinomycin for injection can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)].
Females
Advise females of reproductive potential to use effective contraception during treatment with dactinomycin for injection and for at least 6 months after the final dose.
Males
Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with dactinomycin for injection and for 3 months after the final dose [see Nonclinical Toxicology (13.1)].
The safety and effectiveness of dactinomycin have been established in pediatric patients with Wilms tumor, rhabdomyosarcoma, Ewing sarcoma, and metastatic nonseminomatous testicular cancer.
The safety and effectiveness of dactinomycin have been established in post-menarchal pediatric patients with gestational trophoblastic neoplasia.
The safety and effectiveness of dactinomycin for injection have not been established in pediatric patients undergoing regional perfusion for locally recurrent or locoregional solid malignancies.
Clinical studies of dactinomycin for injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Dactinomycin, USP is one of the actinomycins, a group of antibiotics produced by various species of Streptomyces. Dactinomycin is the principal component of the mixture of actinomycins produced by Streptomyces parvullus. Unlike other species of Streptomyces, this organism yields an essentially pure substance that contains only traces of similar compounds differing in amino acid content of the peptide side chains. The empirical formula is C62H86N12O16 and the structural formula is:
Dactinomycin for Injection, USP is a sterile, yellow to orange, lyophilized powder for injection by intravenous route or by regional perfusion after reconstitution. Each vial contains 0.5 mg (500 mcg) of dactinomycin, USP and 20 mg of mannitol.
Dactinomycin for injection is a cytotoxic actinomycin that binds DNA and inhibits RNA synthesis. The cytotoxic activity of dactinomycin has been demonstrated in animal models of different human cancers.
Dactinomycin exposure-response relationships and the time course of pharmacodynamics response are unknown.
The distribution and excretion of radiolabeled dactinomycin (3Hactinomycin D) were assessed in three adult patients with malignant melanoma.
Distribution
3H actinomycin D is concentrated in nucleated cells and does not penetrate the blood-brain barrier.
Elimination
Excretion
Following administration of radiolabeled dactinomycin, approximately 30% was recovered in urine and feces in one week.
Specific Populations
Pediatric Patients
Published studies and population analyses in patients ≤ 21 years of age with cancer report a trend of increasing systemic dactinomycin clearance with increasing body weight.
Drug Interaction Studies
Published in vitro studies report that dactinomycin may be a substrate of the P-glycoprotein and OATP1B3 transporter systems.
Dactinomycin is a carcinogen in animals. Local sarcomas were produced in mice and rats after repeated subcutaneous or intraperitoneal injections. Mesenchymal tumors occurred in male rats given intraperitoneal injections of 50 mcg/kg, 2 to 5 times per week, for 18 weeks, at doses (based on body surface area) 0.5 times the clinical dose of 1,250 mcg/m2.
Dactinomycin was mutagenic in several in vitro and in vivo test systems including human fibroblasts and leukocytes, and HeLa cells. DNA damage and cytogenetic effects have been demonstrated in the mouse and the rat.
www.osha.gov/SLTC/hazardousdrugs/index.html
Dactinomycin for injection, USP is a lyophilized powder. In the dry form the compound is an amorphous yellow to orange powder. The solution is clear, gold or yellow to orange colored and essentially free from visible particles. Dactinomycin for injection, USP is supplied in vials containing 0.5 mg (500 micrograms) of dactinomycin and 20.0 mg of mannitol.
NDC 67457-513-05: 0.5 mg/vial in 2 mL single-dose vial; individually boxed
NDC 67457-513-99: 0.5 mg/vial in 2 mL single-dose individually boxed vials in outer carton (12s).
Storage: Store at 20º to 25ºC (68º to 77ºF); [see USP Controlled Room Temperature] Protect from light and humidity.
Special Handling: Animal studies have shown dactinomycin to be corrosive to skin, irritating to the eyes and mucous membranes of the respiratory tract and highly toxic by the oral route. It has also been shown to be carcinogenic, mutagenic, embryotoxic and teratogenic. Due to the drug’s toxic properties, appropriate precautions including the use of appropriate safety equipment are recommended for the preparation of dactinomycin for injection for parenteral administration. Inhalation of dust or vapors and contact with skin or mucous membranes, especially those of the eyes, must be avoided. Avoid exposure during pregnancy. The National Institutes of Health presently recommends that the preparation of injectable antineoplastic drugs should be performed in a Class II laminar flow biological safety cabinet. Personnel preparing drugs of this class should wear chemical resistant, impervious gloves, safety goggles, outer garments and shoe covers. Additional body garments should be used based upon the task being performed (e.g., sleevelets, apron, gauntlets, disposable suits) to avoid exposed skin surfaces and inhalation of vapors and dust. Appropriate techniques should be used to remove potentially contaminated clothing.
Several other guidelines for proper handling and disposal of antineoplastic drugs have been published and should be considered.1-4
Accidental Contact Measures: Should accidental eye contact occur, copious irrigation for at least 15 minutes with water, normal saline or a balanced salt ophthalmic irrigating solution should be instituted immediately, followed by prompt ophthalmologic consultation. Should accidental skin contact occur, the affected part must be irrigated immediately with copious amounts of water for at least 15 minutes while removing contaminated clothing and shoes. Medical attention should be sought immediately. Contaminated clothing should be destroyed and shoes cleaned thoroughly before reuse (see PRECAUTIONS, General and DOSAGE AND ADMINISTRATION, Preparation of Solution for Intravenous Administration).
Secondary Malignancy or Leukemia
Advise patients of the increased risk of secondary malignancies [see Warnings and Precautions (5.1)].
Veno-occlusive Disease
Advise patients about the symptoms of VOD and to seek medical attention if they develop new onset jaundice, abdominal distention, or right upper quadrant pain [see Warnings and Precautions (5.2)].
Myelosuppression
Advise patients to contact their healthcare provider for any signs or symptoms of myelosuppression or infection [see Warnings and Precautions (5.4)].
Severe Mucocutaneous Reactions
Advise patients of the risk of severe mucocutaneous reactions and to contact their health care provided for new skin lesions, mouth sores or oropharyngeal lesions [see Warnings and Precautions (5.5)].
Renal Toxicity or Hepatotoxicity
Advise patients of the need for periodic laboratory testing to monitor for renal toxicity and hepatotoxicity [see Warnings and Precautions (5.7, 5.8)].
Potentiation of Radiation Toxicity and Radiation Recall
Advise patients of the risk of increased radiation-induced gastrointestinal, myelosuppression and skin toxicity [see Warnings and Precautions (5.9)].
Embryo-Fetal Toxicity
Advise females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.10), Use in Specific Populations (8.1)].
Advise females of reproductive potential to use effective contraception during treatment with dactinomycin for injection and for 6 months after final dose [see Use in Specific Populations (8.3)]. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with dactinomycin for injection and for 3 months after final dose [see Use in Specific Populations (8.3) ].
Lactation
Advise females not to breastfeed during treatment with dactinomycin for injection and for 14 days after the final dose [see Use in Specific Populations (8.2)].
Manufactured for:
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.
Manufactured by:
Mylan Laboratories Limited
Bangalore, India
NDC 67457-513-05
Dactinomycin for Injection, USP
500 mcg (0.5 mg)/vial
For Preparation of Intravenous Solutions
CAUTION: CYTOTOXIC AGENT
Lyophilized
Mylan
Rx only
Single-Dose Vial
NDC 67457-513-99
Dactinomycin for Injection, USP
500 mcg (0.5 mg)/vial
For Preparation of Intravenous Solutions
CAUTION: CYTOTOXIC AGENT
Mylan
Lyophilized
Rx only
12 Single-Dose Vials
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 67457-513-05 | EA - Each | 67457-513 | 64bdb666-35a1-4ddb-9155-a831e7f90f3b | 1 | 2018-02-20 |
| 67457-513-99 | EA - Each | 67457-513 | 0b8a9de7-18ee-432b-bd09-724378631367 | 1 | 2018-02-20 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67457-513 | 67457-513-05, 67457-513-99 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DACTINOMYCIN | 1CC1JFE158 | ACTIB |
| MANNITOL | 3OWL53L36A | IACT |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203385-001 | DACTINOMYCIN | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2017-11-09 |
| Application-product | TE code |
|---|---|
| A203385-001 | AP |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2017-11-09 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2017-11-09 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2017-11-09 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2017-11-09 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2017-11-09 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2017-11-09 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2017-11-09 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2017-11-09 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2017-11-09 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2017-11-09 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2017-11-09 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2017-11-09 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2017-11-09 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2017-11-09 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2017-11-09 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2017-11-09 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | 2017-11-09 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | 2017-11-09 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | 2017-11-09 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | 2017-11-09 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | 2017-11-09 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | 2017-11-09 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | 2017-11-09 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | 2017-11-09 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | 2017-11-09 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | 2017-11-09 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | 2017-11-09 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | 2017-11-09 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | 2017-11-09 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2017-11-09 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | RS | 2017-11-09 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | 2017-11-09 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | 2017-11-09 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | 2017-11-09 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | 2017-11-09 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | 2017-11-09 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | 2017-11-09 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | 2017-11-09 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | 2017-11-09 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A203385-001 | DACTINOMYCIN | 0.5MG/VIAL | INJECTABLE / INJECTION | AP | 2017-11-09 | f41ea6bd6efb… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A203385-001 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A203385-001 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A203385-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203385-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203385-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203385-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203385-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203385-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203385-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203385-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203385-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203385-001 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203385-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203385-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203385-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A203385-001 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203385-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A203385-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A203385-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A203385-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A203385-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A203385-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A203385-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A203385-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A203385-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A203385-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A203385-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A203385-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A203385-001 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A203385-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A203385-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A203385-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A203385-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A203385-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A203385-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A203385-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A203385-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A203385-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A203385-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A203385-001 | AP | 1 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| 11743b57-8ce1-4b4e-919b-eecd4312cbf1 | 5dc19443-1bac-4bb4-893e-e791b72b3d26 | 2018-10-25 | Warnings, Adverse reactions | 5dc19443-1bac-4bb4-893e-e791b72b3d26 |
Adverse event summaries are temporarily unavailable. Other product information remains available.